TY - JOUR
AB - SAP538 CLINICAL EVALUATION OF NOVEL PTH(1-84) BIOINTACT ASSAYS IN HEMODIALYSIS PATIENTS Manfred Hecking Manfred Hecking 1Medical University of Vienna Alexander Kainz Alexander Kainz 1Medical University of Vienna Bernhard Bielesz Bernhard Bielesz 1Medical University of Vienna Max Plischke Max Plischke 2Department of Medicine III, Divison of Nephrology and Dialysis, Medical University Vienna, Vienna, Austria Georg Beilhack Georg Beilhack 1Medical University of Vienna Walter H. Hoerl Walter H. Hoerl 1Medical University of Vienna Gere Sunder-Plassmann Gere Sunder-Plassmann 3Medical University Vienna, Department of Medicine III, Division of Nephrology & Dialysis, Vienna, Austria Christian Bieglmayer Christian Bieglmayer 1Medical University of Vienna Abstract Introduction and Aims: In Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) patients, most treatment decisions concerning vitamin D use, administration of calcimimetics and parathyroidectomy are guided by parathyroid hormone (PTH) levels. The quality of the PTH test has been judged of paramount importance. Various fully automated assays are currently available, measuring either full-length PTH(1-84) together with N-terminal truncated fragments (immunometric “second generation” tests, misleadingly called “intact PTH assays”) or PTH(1-84) alone (“third generation tests”, so called “biointact PTH assays”). In the present study on hemodialysis patients, we assessed the technical and clinical performance of two novel automated biointact PTH(1-84) assays: the Elecsys® PTH(1-84) assay from Roche Diagnostics (Ro) and DiaSorin's LIAISON® PTH(1-84) assay (DS). Specifically, we aimed to evaluate 1) the comparability of Ro and DS PTH(1-84) levels; 2) the correlation between biointact PTH and intact PTH; 3) the association of PTH values from biointact and intact PTH assays with serum phosphate, as well as 4) with serum creatinine concentrations. Methods: We recorded demographics, patient and dialysis treatment characteristics, and pharmacotherapy for CKD-MBD. Laboratory work-up included total serum calcium, phosphate and creatinine, besides intact Elecsys® PTH (Ro) and biointact PTH(1-84) (Ro and DS). PTH levels were measured on immunoassay analyzers (Ro Cobas e411R and DS LIAISON® ) with the respective test kits. Statistical methods included Passing & Bablok regression fit (aims 1 and 2), Bland-Altmann plots (aim 1), multiple linear regression analysis (aim 3), and linear regression fit (aim 4). Local ethics approval: EK#452/2010. Results: 121 patients on dialysis for 3.5 ± 3.8 years, with serum phosphate 1.9 ± 0.6 mmol/L participated in the study. Intact PTH levels were 374 ± 428 pg/ml, and biointact PTH(1-84) concentrations 231 ± 255 pg/ml (Ro), respectively 235 ± 272 pg/ml (DS; all values on average ± SD). The regression equation Ro = 0.87×DS + 19.60 describes the correlation between both biointact assays (r = 0.98). Bland-Altmann plots revealed an average ± 2 SD bias of 10 ± 27 below 200 pg/ml; above 200 pg/mL the bias was -32 ± 157 (Ro minus DS PTH[1-84]) . Comparisons between biointact PTH(1-84) versus intact PTH are displayed in the figure.5 View largeDownload slide View largeDownload slide The association between PTH and phosphate, with various levels of adjustment, was very similar, regardless of the PTH assay, as shown by only negligible differences in p-values or estimated coefficients of determination for PTH. PTH levels measured with all three assays were significantly associated with serum creatinine, but only in patients with residual renal function ( > 0 mL urine per day; r = 0.44 for both PTH(1-84) assays, r = 0.46 for intact PTH, all p < 0.001). Conclusions: The results obtained by the automated biointact PTH(1-84) assays from Ro and DS were well correlated, but showed increased deviations at higher concentrations. The concentration of PTH(1-84) is roughly two third of the PTH concentration obtained with an intact PTH assay (full-length PTH plus fragments). Importantly, this has to be considered, if published threshold levels obtained by intact PTH assays are used for guideline-based treatment decisions. The association between serum creatinine and PTH levels in hemodialysis patients with residual renal function deserves further study, e.g. investigation of its usefulness as a prognostic marker. SAP539 EVALUATION OF INTACT PTH IN HEAMODIALYZED PATIENTS WITH A THIRD GENERATION KIT. Sydney Benchetrit Sydney Benchetrit 1Dpt of Nephrology and Hypertension, Meir Medical Center Janice Green Janice Green 2Renal Physiology Laboratory, Department of Nephrology and Hypertension, Meir Medical Center, Jacques Bernheim Jacques Bernheim 3Renal Physiology Laboratory, Department of Nephrology and Hypertension, Meir Medical Center Eliezer Golan Eliezer Golan 4Department of Nephrology and Hypertension, Meir Medical Center Abstract Introduction and Aims: The measurement of intact PTH remains a significant clinical problem in heamodialyzed patients because of large variations between different available kits which recognize C- terminal fragments.The available kit which recognizes only the intact PTH (1-84) (PTH2) uses radioisotopes, must be performed manually, is time consuming and therefore cannot be used in practice for monthly follow up. The emergence of new drugs for the treatment of secondary hyperparathyroidism in heamodialysed (HD) patients require a more accurate and simple test to optimize and follow the therapeutic goals.The new Diasorin 1-84 PTH (PTH3) is a third generation assay that measures only 1-84 PTH and is supposed to provide more accurate results in the assessment of this hormone in HD patients.The aim of the present study was to evaluate in a population of HD patients' the accuracy of the Diasorin 1-84 PTH (PTH3) assay. Methods: Blood samples were collected from 140 HD patients, before starting the dialysis session. PTH was measured concomitantly by N-Tact PTH (PTH2) immunoradiometric assay (Diasorin) and with the Liaison Diasorin 1-84 PTH (PTH3), a two site automated sandwich immunoassay. Results: We found a high positive correlation between t he goldstandard N-Tact PTH (PTH2) and the Diasorin PTH (1-84) (PTH3) assay (R2 = 0.93). The mean was respectively (181.8 ± 172.3 vs 151.6 ± 143.7 pg/ml ) for N-Tact PTH and Liaison Diasorin (1-84).7 View largeDownload slide View largeDownload slide Conclusions: PTH results obtained with the Diasorin PTH (1-84) assay showed a high correlation with the goldstandard PTH RIA and can offer a more available and technically simple method for the follow up of PTH levels in HD patients. SAP540 PLASMA FATTY ACID COMPOSITION IS ASSOCIATED WITH BONE MINERAL DENSITY IN HAEMODIALYSIS PATIENTS. Nobuyuki Oyake Nobuyuki Oyake 1Otsuka Clinic Keiko Suzuki Keiko Suzuki 1Otsuka Clinic Saki Itoh Saki Itoh 2Shimane University Faculty of Medicine Kazuaki Tanabe Kazuaki Tanabe 2Shimane University Faculty of Medicine Abstract Introduction and Aims: Epidemiological studies reveal that fatty acid (FA) composition is associated with cardiovascular disease, diabetes and abnormal bone metabolism in general population. Reduced bone mineral density (BMD) is commonly observed in dialysis patients and leads to bone fracture and poor outcome. However, there are few researches on a link between BMD and FAs in these patients. In the present study, we evaluated plasma FAs and estimated desaturase indices, and clarified its link with BMD. Methods: In 66 patients (mean age 67.1 + -11.3 yr, 38% women, duration of dialysis 11.8 + -9.3 yrs) receiving regular haemodialysis treatment without any n-3 fatty acid supplement in our hospital, we measured plasma FA composition using gas chromatography and estimated stearoyl-CoA desaturase (SCD), delta 5 desaturase (D5D) and delta 6 desaturase (D6D). BMD in the distal 1/3 of the radius was examined by dual X-ray absorptiometry and calculated the annual changes (delta BMD). Bone-specific alkaline phosphatase (BAP), osteocalcin (OC), tartrate-resistant acid phosphatise isoform 5b (TRACP-5b) and whole PTH levels were also measured. Results: The BMD in the distal 1/3 radius significantly correlated with SCD, HD duration and TRACP-5b (r = -0.263, p < 0.05, r = 0.342, p < 0.01, r = -0.296, p < 0.05, respectively). The annual change in the BMD correlated with duration of dialysis (r = 0.365, r < 0.005). In stepwise multiple regression analysis, we found that the BMD was independently associated with SCD, the ratio of eicosapentaenoic acid to arachidonic acid, age, gender, duration of dialysis and serum albumin levels (t = -2.67, p < 0.01, t = 2.03, p < 0.05, t = -2.39, p < 0.05, t = 5.46, p < 0.0001, t = -4.42, p < 0.0001, t = -3.23, p < 0.01, respectively). Furthermore, the annual change in the BMD was significantly associated with duration of HD and hyperparathyroidism treated with cinacalcet (t = 4.57, p < 0.0001, t = -3.02, p < 0.005, respectively). Conclusions: Although a time-dependent decline in the BMD is enhanced by hyperparathyroidism in haemodialysis patients, the BMD is possibly associated with fatty acid composition and metabolism in part. Further prospective study is needed to clarify the impact of fatty acid composition on the alteration in the BMD. SAP541 ASSOCIATION OF SERUM PENTOSIDINE LEVEL WITH THE PREVALENCE OF FRACTURES IN HEMODIALYSIS PATIENTS Akira Fujimori Akira Fujimori 1Konan Hospital, Kobe, Japan Akira Fujimori Akira Fujimori 1Konan Hospital, Kobe, Japan Shioko Okada Shioko Okada 1Konan Hospital, Kobe, Japan Kiyoko Yamamoto Kiyoko Yamamoto 1Konan Hospital, Kobe, Japan Makoto Sakai Makoto Sakai 1Konan Hospital, Kobe, Japan Nozomu Kamiura Nozomu Kamiura 1Konan Hospital, Kobe, Japan Abstract Introduction and Aims: Fractures are a prevailing complication in dialysis patients. Although the association of older age, female gender, diabetes, and malnutrition with fractures has been described, the significance of bone quality is unknown. Pentosidine and homocysteine appear to be useful biochemical markers for bone quality. Therefore, we studied the association of pentosidine, homocystein, and other factors with the prevalence of fractures in hemodialysis patients. Methods: Blood levels of pentosidine, homocystein, albumin, creatinine, Whole PTH, bone-specific alkaline phosphatase (BAP), osteocalcin (OC), and undercarboxylated osteocalcin (ucOC) were determined before hemodialysis. Bone mineral density (BMD) of the lumbar spine (L1- L4, vertebrae with compression fractures were excluded), proximal femur, and the distal 33% site of the radius was determined by dual-energy x-ray absorptiometry using DPX BRAVO (General Electric, Fairfield, CT) and expressed by percentages of young adult means of both genders. Presence of vertebral and hip fractures was determined by history-taking and X-ray films. These data were collected from 81 patients (70.4 +; 9.9 of age, 8.0 +; 7.1 of dialysis vintage, 51 males, 30 females, 30 diabetics, 51 non-diabetics) on hemodialysis in our hospital. Results: Vertebral and hip fractures were identified in 19 patients. Comparison between patients with and without fractures was performed using Mann-Whitney U test. Patients with fractures showed older age (p = 0.005), lower Cr (p = 0.011), lower Whole PTH (p = 0.020), lower lumbar BMD (p = 0.025), lower hip BMD (p = 0.001), and higher pentosidine (p = 0.017). However, significant differences were not found in BMI, radius BMD, gender, diabetes, vintage, albumin, BAP, OC, or ucOC Then multivariable logistic regression analysis was performed with the prevalence of fractures as the dependent variable. In a stepwise model, pentosidine, Cr, and hip BMD were chosen as independent variables, while age, Cr, Whole PTH, or lumbar BMD was not chosen (Table 1). 1 Table 1. Results of stepwise multiple regression analysis.    These results show that low BMD, malnutrition estimated by low Cr, and bone fragility indicated by high pentosidine are associated with the prevalence of fractures. Pentosidine could be independently related to the incidence of fractures in uremic patients. Pentosidine is a protein-bound uremic toxin and one of well-known advanced glycation end products. The association of pentosidine with fractures has been described in diabetic patients. Serum pentosidine levels paralle to its accumulation in the bone. It would deteriorate collagen properties by decreasing its hydroxylysine residues, resulting in increased risk of fractures. Conclusions: Serum pentosidine is associated with the prevalence of fractures. Prospective study should be carried out to evaluate the significance of pentosidine as a risk factor for incident fractures in uremic patients. SAP542 STRONG RELATIONSHIP BETWEEN BONE MICROARCHITECTURE AND ADIPONECTIN IN MAINTENANCE HEMODIALYSIS Pelletier Solenne Pelletier Solenne 1Hopital Edouard Herriot Fitsum Guebre-Egziabher Fitsum Guebre-Egziabher 1Hopital Edouard Herriot Justine Bacchetta Justine Bacchetta 2Hopital Femme Mere Enfant Jocelyne Drai Jocelyne Drai 3Hopital Lyon Sud Michel Richard Michel Richard 1Hopital Edouard Herriot Roland Chapurlat Roland Chapurlat 1Hopital Edouard Herriot Denis Fouque Denis Fouque 4Hôpital Edouard Herriot, Lyon, France Abstract Introduction and Aims: Osteocalcin is a circulating peptide secreted by osteoblasts involved in the regulation of energy metabolism. Experimental data suggest a regulation of adipocyte by bone, with a stimulation of adiponectin synthesis by osteocalcin. We prospectively assessed the relationship between bone and adipose tissue in maintenance hemodialysis patients. Methods: Serum osteocalcin, adiponectin and bone microarchitecture (HR-pQCT; Scanco Inc, Switzerland) were studied in a cohort of 56 patients (21 women, 14 diabetic). Results: Mean age was 51 ± 16 yr, adiponectin 15 040 ± 8 770 ng/ml, osteocalcin 323 ± 333 ng/ml. Adiponectin strongly and positively correlated with osteocalcin (log-transformed r = 0.37, p = 0.008). Furthermore, by HR-pQCT we observed strong inverse relationships between serum adiponectin and distal tibia total bone mineral density (p < 0.001), cortical thickness (p < 0.001), trabecular density (p < 0.02), number (p < 0.001) and positive with trabecular separation (p < 0.02). Conclusions: We describe for the first time a strong and positive relationship between serum osteocalcin and adiponectin in hemodialysis patients. In addition, there seems to be a global inverse relationship between serum adiponectin and total bone density, cortical and trabecular microarchitecture. Further studies are warranted to test if high levels of adiponectin could be detrimental to bone quality. SAP543 BONE TOURNOVER ABNORMALITIES IN DIALYSED PATIENTS. Zbigniew Nowak Zbigniew Nowak 1Military Institute of Medicine, Warsaw, Poland Zbigniew Nowak Zbigniew Nowak 2Military Institute of Medicine Kade Grzegorz Kade Grzegorz 1Military Institute of Medicine, Warsaw, Poland Konieczna Maria Konieczna Maria 1Military Institute of Medicine, Warsaw, Poland Wańkowicz Zofia Wańkowicz Zofia 1Military Institute of Medicine, Warsaw, Poland Abstract Introduction and Aims: The evaluation of mineral and bone disorder (MBD) in everyday practice based on non- invasive measurements. Biochemical bone turnover markers have been considered as a potentially useful tool for diagnosis of bone metabolism in dialysed patients. TRACP 5b- resorbtion marker is expressed in bone resorbing osteoclasts and secreted into the circulation. During the process of collagen type I synthesis, the N- and C-terminal procollagen propeptides are cleaved from the newly formed molecule and are released into the circulation.The aim of the study was to compare clinical usefulness of bone turnover markers (PINP and TRAP 5b) with the standard marker of bone metabolism which is iPTH. Methods: We studied 92 patients: 64 on hemodialysis (HD) for 43 ± 28 months (38M, 26F aged 61 ± 25 yr.) and 28 on peritoneal dialysis (PD) for 49 ± 29 months (14M. 12F, aged 57 ± 25 yr.). According to the level of iPTH the whole group was divided in 3 subgroups: group1 low iPTH < 100pg/ml, group2 medium iPTH 100–450pg/ml and group3 high > 450pg/ml The following parameters were determined in serum: PINP, TRAP 5b, iPTH, Calcium, Phosphate. PINP was measured using radioimmuno assay; TRAP 5b activity was measured using assay Bone TRAP™ . Intact PTH was measured using immunoradiometric assay (Diasorin USA). Results: In patients with high turnover ROD-(group 3.) significantly higher values of PINP and TRACP were found in comparison with low turnover ROD -group1.2 Table 1.     We found significant correlation between iPTH and PINP ( r = 0,7078; p < 0,001) and between iPTH and TRAP ( r = 0,6872, p < 0,001). We also didn't find any significant correlations between values of PINP as well as TRAP and gender, age and method of dialysotherap Conclusions: Our results indicate that monitoring of bone abnormalities with TRACP5b, PINP and iPTHmight be useful in dialysed patients. SAP544 BONE HISTOMORPHOMETRY IN PATIENTS UNDERGOING DIALYSIS WITH SERIOUS CALCIFICATIONS Kamil Zamboch Kamil Zamboch 1Department of Internal Medicine III, University Hospital and Palacky University Olomouc, Czech Republic Jana Zahalkova Jana Zahalkova 2Sternberk Hospital, Department of Hemodialysis, Czech Republic Zdenka Kosatikova Zdenka Kosatikova 1Department of Internal Medicine III, University Hospital and Palacky University Olomouc, Czech Republic Petra Skypalova Petra Skypalova 3Department of Pathology, University Hospital and Palacky University Olomouc, Czech Republic Josef Skarda Josef Skarda 3Department of Pathology, University Hospital and Palacky University Olomouc, Czech Republic Abstract Introduction and Aims: Patients with high cardiovascular risk have relatively high probability of both extreme forms of renal osteopathy (RO) based on bone resorption. The targeted therapy, however, differs substantially. Complex bone histomorphometry in individual forms of RO with the determination of different bone components may faciliate a targeted and safe treatment of MBD-CKD (mineral bone disease in chronic kidney disease). Methods: An open prospective pilot study was aimed at a cohort of 12 patients undergoing chronic diaysis (N = 12, females = 8, males = 4, average age 74 years, average dialysis treatment = 38 months). All the patients had severe progressive vascular calcifications. They underwent trephine biopsy with the acquisition of bone tissue followed by histomorphometric assessment of static parameters–relative volume (V) of the bone structure, relative V of osteoid, V of trabecular bone, fraction of osteoid and bone mineral V, surface of the bone structure covered by osteoid, thickness of the beam as well as osteoid component, and the relative V of trabecular bone to spongy bone. We assessed also the dynamic parameters of RO, based on tetracycline lines (TTC). Laboratory evaluation included serum levels of markers related to bone formation and resorption. We determined the volumes of parathyroid glands (PT) and the Z-score using the densitometry (DEXA). Results: Based on the histomorphometry, we identified the mixed form of RO in eight patients. Six of them had high-turnover form of MBD. The last four patients had ABD (adynamic bione disease). Positive correlations at 0,01 significance level were identified between the volume of the bone beam and procollagen 1 (-0.345) and calcitonin (0.224), and between trabecular bone V and serum level of osteocalcin (0,721). Statistical relationship was also between cross- laps, C-telopeptide of collagen 1 and Z-score based on DEXA (-0.681, respectively -0.747). There was a relationship between TTC lines, bone tissue V (0.705) and bone beam thickness (-0.742) and between osteoid and bone mineral V (0.665) with the length of dialysis treatment. We found also the relationship between the volume of PT and procollagen 1 (0.830). Conclusions: We found out that the thickness of TTC lines best correlates with the extent of bone tissue turnover and is the best parameter discriminating hypersostosis and ABD. We confirmed the relationship between osteoblast activity and the increase of trabecular bone V. In complicated cases and in risk patients, the histomorphometry of the bone maintains its pivotal role for complex evaluation of bone changes in MBD-CKD (recommendation of K/DOQi, ERA/EDTA). Supported by the grant 2010/01 of the Czech nephrology society. SAP545 EFFECT OF HIGH GLUCOSE CONCENTRATION ON THE OSTEOBLAST FUNCTION Juliana Cunha Juliana Cunha 1Federal University of São Paulo, São Paulo, Brazil Mirian Boim Mirian Boim 1Federal University of São Paulo, São Paulo, Brazil Vanessa Ferreira Vanessa Ferreira 1Federal University of São Paulo, São Paulo, Brazil Marcelo Naves Marcelo Naves 1Federal University of São Paulo, São Paulo, Brazil Abstract INTRODUCTION: Adynamic bone disease (ABD) is characterized by a decrease in bone turn over due to decreased of bone cells (osteoblasts, osteoclasts and osteocytes) number and extracellular matrix production. ABD and osteoporosis as well, are frequently found in diabetic patients and these diseases can be worsened in the presence of diabetic nephropathy. The pathophysiology of bone disease in consequence of diabetes remains controversial and thus, our aim was to evaluate the effect of high concentration of glucose on osteoblast function thought an in vitro model using a rat immortalized osteoblast cell line (MC3T3-E1). Methods: After 14 days of differentiation, MC3T3-E1 cells were stimulated with high glucose (30mM) for 24h. Mannitol (30mM) was used as an osmotic control. mRNA expression levels of PTH receptor (PTH1R), collagen I (COL1), Nuclear Receptor Activator kappa B ligand (RANKL), responsible for activating osteoclasts, Osteoprotegerin (OPG), the main inhibitor of RANKL and alkaline phosphatase (ALP), an essential enzyme for the mineralization process, were estimated by Real-Time PCR. The mineralization capacity was analyzed by von Kossa stain method. Results: MC3T3-E1 cells stimulated with high glucose presented increased mRNA levels of PTH1R, COL1, RANKL, OPG, whereas ALP decreased significantly in comparison to control. Interestingly similar (although less intense) results were observed in the osmotic control group. The mineralization process was decreased either by glucose and mannitol. CONCLUSION: Hyperglycemia and hyperosmolarity can induce osteoblast dysfunction and thus damage bone tissue. A reduction in the mineralization process (reduced ALP) more than osteoclast activation (increased RANKL and OPG) has important role in bone alterations induced by high glucose environment. Thus a deficit in the bone mineralization may contribute to the pathophysiology of bone disease induced by diabetes. SAP546 A NOVEL AND SIMPLE METHOD FOR EVALUATING THE AMOUNT OF INTRADIALYTIC PHOSPHATE REMOVAL Hiroshi Kikuchi Hiroshi Kikuchi 1Toyosaka Hospital, Niigata , Japan Hisaki Shimada Hisaki Shimada 2Kidney Center of Shinraku-En Hospital, Niigata, Japan Yasumi Takimoto Yasumi Takimoto 2Kidney Center of Shinraku-En Hospital, Niigata, Japan Ryo Karasawa Ryo Karasawa 3Toyosaka Hospital, Niigata, Japan Masaaki Shimotori Masaaki Shimotori 2Kidney Center of Shinraku-En Hospital, Niigata, Japan Kozo Ikarashi Kozo Ikarashi 2Kidney Center of Shinraku-En Hospital, Niigata, Japan Noriko Saito Noriko Saito 2Kidney Center of Shinraku-En Hospital, Niigata, Japan Shigeru Miyazaki Shigeru Miyazaki 2Kidney Center of Shinraku-En Hospital, Niigata, Japan Shinji Sakai Shinji Sakai 2Kidney Center of Shinraku-En Hospital, Niigata, Japan Masashi Suzuki Masashi Suzuki 2Kidney Center of Shinraku-En Hospital, Niigata, Japan Abstract Introduction and Aims: Greater serum phosphate (iP) concentration is a risk for death in hemodialysis (HD) patients. No method for easy and accurate evaluation of the amount of intradialytic iP removal (Rp) had been established. We presented a novel formula in 4-hour (h)-HD patients at ERA-EDTA congress in 2011. The aim of this study is to establish a method for accurate evaluation of Rp in not only 4-h-HD patients but also from 3 to 5-h-HD. Methods: We previously evaluated Rp in 4-h-HD as follows. (a)We calculated the accumulated differences of iP between pre- and post-dialyzer serum with blood data sampled hourly. It was assumed to be evaluated Rp from plasma (eRpp). With comparison of eRpp and actual Rp (aRp), which was measured with collected dialysate, evaluated Rp (eRp) was 1.102 times of eRpp. (b) Hourly sampled blood data were evaluated from data at start and end of HD. We substituted the evaluated value for the formula made in (a) and obtained a formula for eRp. (c)To simplify the formula, we assumed that hematocrit (Ht) and Pv/Pa were respectively constant. Minimum difference between eRp and aRp was achieved when we assumed as follows; the constant Ht was Ht at the time of 40% of completed HD session and Pv = 0.125Pa, where Pv = iP concentration in post-dialyzer serum, Pa = that in pre-dialyzer. (d)We established the formula; eRp = 33.06 Qb(1-(3Ht0 + 2Ht4)/500) (0.5 + 1.75(UN4/UN0)1/4)Pa0 + 4.668Pa4) + 0.0689UF(Pa0 + Pa4), and verified the accuracy, where UN = serum urea nitrogen concentration, UF = amount of ultrafiltration (dl/session), Qb = blood flow rate (dl/min). In current study, we added the required data for evaluating Rp in 3 and 5- h-HD. Blood samples from pre- and post-dialyzer were drawn in 20 of 4-h-HD and 12 of 5-h- HD patients at pre, post-HD and one hour before end of HD. aRp of last one hour and aRp of the former hours were measured with dialysate collection. Then, the same evaluation procedures provided the formulas for eRp in 3 and 5-h-HD. Using the formulas in 3, 4 and 5- h-HD, we tried to get a new formula for eRp in any 3 to 5-h-HD. For this aim, in 6 of 3.5-h- HD, 20 of 4-h-HD and 7 of 4.5-h-HD patients, blood at start and end of HD were sampled and dialysate were collected. Using these data, we obtained a formula for eRp in any 3 to 5-h-HD. The accuracy of the formula was verified with comparing aRp and eRp in 65 patients. Results: With same evaluation procedure in 4-h-HD,we obtained the formulas for eRp in 3 and 5-h- HD respectively as follows; eRp(3h) = 33.06 Qb(1-(3Ht0 + 2Ht3)/500) (0.625 + 1.75(UN3/UN0)1/3)Pa0 + 2.755Pa3) + 0.0689UF(Pa0 + Pa3), eRp(5h) = 33.06 Qb(1- (3Ht0 + 2Ht5)/500) (0.375 + 1.75(UN5/UN0)1/5)Pa0 + 6.735Pa5) + 0.0689UF(Pa0 + Pa5). From three formulas in 3, 4 and 5-h-HD, eRp was expressed with function of time (f(T)) as follow; eRp = 33.06Qb(1-(3Ht0 + 2HtT)/500)((1-0.125T + 1.75(UNT/UN0)1/T)Pa0 + (f(T)-0.125T)PaT) + 0.0689UF(Pa0 + PaT). Substituting aRp, Qb, Ht, T, UN, Pa and UF for this formula provided f(T) of all patients. The average of f(3), f(3.5), f(4), f(4.5) and f(5) were respectively calculated. From regression analysis, f(T) could be written as follow; f(T) = 1.851T-2.174. Finally, we established the formula for eRp in any 3 to 5-h-HD as follow; eRp = 33.06 Qb(1- (3Ht0 + 2HtT)/500) ((1-0.125T) + 1.75(UNT/UN0)1/T)Pa0 + (1.726T- 2.174)PaT) + 0.0689UF(Pa0 + PaT). eRp calculated with this formula was proved to be extremely similar to aRp (Fig; y = 0.909x + 65.7, R = 0.945, P < 0.001). Conclusions: We established a simple method for accurate evaluation of Rp in any 3 to 5-h-HD patients.1 View largeDownload slide View largeDownload slide SAP547 EFFECT OF CINACALCET HYDROCHLORIDE (CH) ON BONE MINERAL DENSITY IN HEMODIALYSIS (HD) PATIENTS WITH SECONDARY HYPERPARATHYROIDISM (SHPT) Hiroaki Ogata Hiroaki Ogata 1Department of Internal Medicine, Showa University Northern Yokohama Hospital. Yokohama, Japan Akiko Takeshima Akiko Takeshima 2Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Japan Masahiro Yamamoto Masahiro Yamamoto 3Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Japan Kei Asakura Kei Asakura 3Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Japan Tadashi Kato Tadashi Kato 3Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Japan Kanji Shishido Kanji Shishido 4Internal Medicine, Kawasaki Clinic, Kawasaki, Japan Fumihiko Koiwa Fumihiko Koiwa 5Department of Internal Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan Masahide Mizobuchi Masahide Mizobuchi 6Department of Nephrology, Showa University School of Medicine, Tokyo, Japan Eriko Kinugasa Eriko Kinugasa 3Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Japan Tadao Akizawa Tadao Akizawa 7Department of Nephrology, Showa University School of Medicine, Yokyo, Japan Abstract Introduction and Aims: CH has been reported to be effective in controlling biochemical abnormalities even in patients with SHPT refractory to vitamin D receptor activators. In addition, observational studies demonstrated to reduce bone fracture risk significantly compared with conventional threatment. However, it is still unknown whether CH could improve BMD in SHPT.The purpose of this study was to assess the effect of CH on BMD in SHPT patients on long-term HD. Methods: Sixty-four SHPT patients on HD (female 31.1%, age 57.0 years, HD vintage 13.0 years) were retrospectively reviewed. BMD in both the ultradistal (UD) and the distal 1/3 (1/3D) sites of radius, which are enriched with cancellous and cortical bone, respectively, was measured with dual X-ray absorptiometry every year, from 2 years prior to CH treatment (conventional treatment) to 2 years after CH treatment. Results: CH significantly decreased serum PTH and ALP concentrations and improved Ca and P control. Although BMD of both UD and 1/3D decreased significantly during the conventional treatment, both BMD did not change significantly during the 2-year CH treatment. The annual changes in BMD of UD and 1/3D were significantly lower during the CH treatment compared with the conventional treatment (UD, -1.29% (95%CI -2.61 to 0.03%) vs 0.79% (- 0.72 to 2.30%), P = 0.0057; 1/3D -2.10% (-2.39 to -1.48%) vs 0.09% (-0.41 to 0.58%), P < 0.0001). Conclusions: CH could prevent to reduction in BMD of both cancellous and cortical bones in patients with SHPT.4 View largeDownload slide View largeDownload slide SAP548 LANTHANUM CARBONATE: A POSTMARKETING OBSERVATIONAL STUDY OF EFFICACY AND SAFETY Francesco Londrino Francesco Londrino 1Ospedale S. Andrea La Spezia Italy Valentina Corbani Valentina Corbani 1Ospedale S. Andrea La Spezia Italy Valentina Corbani Valentina Corbani 1Ospedale S. Andrea La Spezia Italy Michela Ardini Michela Ardini 1Ospedale S. Andrea La Spezia Italy Valeria Falqui Valeria Falqui 1Ospedale S. Andrea La Spezia Italy Tito Zattera Tito Zattera 1Ospedale S. Andrea La Spezia Italy Giuseppe Rombola' Giuseppe Rombola' 1Ospedale S. Andrea La Spezia Italy Abstract Introduction and Aims: Hyperphosphatemia is associated with morbidity and mortality in hemodialysis patients. The use of calcic-chelators is restricted by the risk of hypercalcemia and vascular calcifications. Sevelamer, a non calcic-chelator, is associated with the risks of metabolic acidosis and poor compliance. Lanthanum carbonate is a non calcic-chelator not associated with these issues. However, accumulation in liver and bone has been reason for concern. Methods: 112 adult patients from 9 hemodialysis centers, with serum phosphorus > 5.5 mg/dl, on hemodialysis for > 1year, were selected for switching to lanthanum carbonate (mean dose: 2189 ± 491 mg daily). Laboratory essay for serum phosphate, serum calcium, PTH, alkaline phosphatase, gGT, AST, ALT and plasma bicarbonate were preformed monthly. Seven patients underwent bone biopsy for evaluation of lanthanum bone content. Results: switching to lanthanum carbonate lead to a reduction in mean serum phosphate levels (-18.2% P < 0.001) and calcium-phosphorus product (-17.6% P < 0.0001). There were no important changes in other variables, except for an increase in transaminases in two patients with pre- existing liver disease who discontinued therapy. An increase in plasma bicarbonate concentration was observed (P = 0.001). Although some lanthanum was detected in bone, its distribution did not follow the mineralization front. Conclusions: lanthanum carbonate is effective and well tolerated, provided that recipients do not have pre- existing liver disease. After 8 months of treatment, lanthanum was not detected in the mineralization front of bone. In hemodialysis patients, lanthanum carbonate does not seem to be involved in metabolic bone disease. SAP549 LANTHANUM CARBONATE (LC) INTERFERES IN MEASUREMENR OF LUMBAR BONE MINERAL DENSITY (BMD) WITH DUAL ENERGY X-RAY ABSORPTIOMETRY (DEXA) IN PATIENTS ON HEMODIALYSIS (HD) Hiroaki Ogata Hiroaki Ogata 1Department of Internal Medicine, Showa University Northern Yokohama Hospital. Yokohama, Japan Yui Takeshige Yui Takeshige 2Showa University Northern Yokohama Hospital, Yokohama Japan Yui Takeshige Yui Takeshige 3Showa University Northern Yokohama Hospital, Yokohama, Japan Masahide Mizobuchi Masahide Mizobuchi 4Department of Nephrology, Showa University School of Medicine, Tokyo, Japan Kantaro Matsuzaka Kantaro Matsuzaka 3Showa University Northern Yokohama Hospital, Yokohama, Japan Masahiro Yamamoto Masahiro Yamamoto 3Showa University Northern Yokohama Hospital, Yokohama, Japan Kanji Shishido Kanji Shishido 5Internal Medicine, Kawasaki Clinic, Kawasaki, Japan Tadao Akizawa Tadao Akizawa 4Department of Nephrology, Showa University School of Medicine, Tokyo, Japan Eriko Kinugasa Eriko Kinugasa 3Showa University Northern Yokohama Hospital, Yokohama, Japan Abstract Introduction and Aims: LC, a non-calcium containing phosphate binder, is widely prescribed in dialysis patients with hyperphosphatemia. LC has been reported to be effective in controlling hyperphosphatemia without calcium overload. However, intestinal residual of LC, which is a transitional metal and is opaque to X-rays, was reported to interfere in BMD measurements with DEXA (Am J Nephrol 32:425,2010). Methods: We retrospectively examined effect of LC use on BMD measurements of lumbar bone (L3-5) and radius (distal 1/3) with DEXA among long-term HD patients with hyperphosphatemia. Results: Total 39 patients on long-term HD (age 59.6 ± 10.5 years, female 17.9%, HD vintage 11.2 ± 4.9 years, diabetes 38.5%) were reviewed. LC significantly reduces serum phosphate and parathyroid levels. Abdominal X-rays showed high density-material in gastrointestinal tract among most patients (76%). Lumbar BMD abruptly increased over 30% in 31.8% patients after LC administration. However, BMD of distal 1/3 radius did not change in all patients with LC. Changes in T and Z score of lumbar bone were significanly higher in patients with LC compared with control subjects without LC. Conclusions: Lumbar BMD measured with DEXA might be overestimated in patients with LC, because of intestinal LC residual. SAP550 LANTHANUM PREVENTS HIGH PHOSPHATE-INDUCED VSMCS OSTEOBLASTIC DIFFERENTATION Paola Ciceri Paola Ciceri 1Laboratory of Experimental Nephrology, Dmco, University of Milan Paola Ciceri Paola Ciceri 1Laboratory of Experimental Nephrology, Dmco, University of Milan Elisa Volpi Elisa Volpi 1Laboratory of Experimental Nephrology, Dmco, University of Milan Irene Brenna Irene Brenna 1Laboratory of Experimental Nephrology, Dmco, University of Milan Francesca Elli Francesca Elli 1Laboratory of Experimental Nephrology, Dmco, University of Milan Elisa Borghi Elisa Borghi 2Laboratory of Microbiology, Dmco, University of Milan Diego Brancaccio Diego Brancaccio 1Laboratory of Experimental Nephrology, Dmco, University of Milan Mario Cozzolino Mario Cozzolino 3Dmco, University of Milan, Renal Division, San Paolo Hospital, Milan, Italy Abstract Introduction and Aims: Phosphate (Pi)-binders are commonly used in dialysis patients to control high Pi levels, that associated with vascular calcification (VC). The aim of this study was to investigate the effects of lanthanum (La3 + ) on the progression of Pi-induced VC in vitro. Methods: Rat vascular smooth muscle cells (VSMCs) were cultured in the presence of high Pi (5 mM) and calcium (Ca) deposition analysis was performed to quantify VC. To investigate VSMCs osteoblastic differentiation, we analyzed a-actin and SM22a protein content and core-binding factor alpha-1 (Cbfa-1/RUNX2) mRNA expression. Results: Pi-induced Ca deposition was inhibited by La3 + chloride (LaCl3), with a maximal effect at 100 μM (59.0 ± 2.5%). Furthermore, we studied the effects on VC of Ca Sensing Receptor (CaSR) agonists. Gadolinium (Gd3 + ) chloride, neomycin, spermine, and the calcimimetic calindol significantly inhibited Pi-induced VC (55.9 ± 2.2%, 37.3 ± 4.7%, 30.2 ± 5.7% and 63.8 ± 5.7%, respectively). To investigate the hypothesis that La3 + reduces the progression of VC by interacting with the CaSR, we performed a concentration-response curve of La3 + in presence of a sub-effective concentration of calindol (10 nM). Interestingly, this curve was shifted to the left (IC50 24.2 μM), compared to the curve in the presence of La3 + alone (IC50 45.5 μM). Interestingly, La3 + was able to prevent the high Pi-induced reduction of both a-actin and SM22a protein content, delaying VSMCs osteoblastic differentiation, with no effects on Cbfa- 1/RUNX2 mRNA expression. Conclusions: We demonstrated that La3 + per se and in combination with calindol reduced significantly the progression of VC. In addition, La3 + preserved VSMCs phenotype by high Pi-induced alterations. These in vitro preliminary data suggest the design for clinical trials to investigate the effects of different treatments for dialysis patients affected by hyperphosphatemia and VC. SAP551 ANALYSIS OF SERUM PHOSPHATE CONTROL AND PHOSPHATE BINDER UTILIZATION IN PATIENTS NEW TO HAEMODIALYSIS Kimberley Farrand Kimberley Farrand 1Shire Pharmaceuticals, Wayne, Pa, USA J. Brian Copley J. Brian Copley 1Shire Pharmaceuticals, Wayne, Pa, USA Jamie Heise Jamie Heise 1Shire Pharmaceuticals, Wayne, Pa, USA Moshe Fridman Moshe Fridman 2Amf Consulting, Los Angeles, Ca, USA Michael Keith Michael Keith 1Shire Pharmaceuticals, Wayne, Pa, USA Arthur Silverberg Arthur Silverberg 1Shire Pharmaceuticals, Wayne, Pa, USA Abstract Introduction and Aims: In patients with CKD, elevated serum phosphate (P) levels are associated with increased all- cause mortality; however serum P can be controlled by dialysis, diet and the use of P binders. Serum P was analysed during the first 9 months of haemodialysis (HD) in CKD patients treated by a US dialysis provider to describe the differences in P levels over time, and to describe patient characteristics associated with the various groups defined below. Methods: Three P level ranges were defined. HD patients new to dialysis were grouped by their average monthly serum P values recorded from months 4 to 9. The group of patients with P consistently in the target range (3.5–5.5 mg/dL [1.13–1.78 mmol/L]) formed the reference for between-group baseline comparisons, and was termed CT. The group of patients consistently in the low range ( < 3.5 mg/dL [1.13 mmol/L]) was termed CL, and in the high range ( > 5.5 mg/dL [1.78 mmol/L]) CH. Groups of patients whose serum P varied between ranges were termed LT, TH and LH (variation between the low and target range, target and high, and low and high, respectively). Changes in binder usage during the study, as well as baseline characteristics were compared to identify any significant differences between the reference (CT) and other groups. Results: Of 47 742 patients, 15.3 % (n = 7301) were in the reference group CT and the majority of patients were in group TH (51.3%, n = 24 469). Patients in groups TH, CH (10.5%, n = 5001) and LH (9.2%, n = 4371) were younger than the reference group, with fewer comorbidities, higher mean serum P and incidence of elevated parathyroid hormone (PTH), and higher levels of binder usage. Patients in groups LT (13.6%, n = 6469) and CL (0.3%, n = 131) were older, with more comorbidities, lower levels of binder usage and with lower PTH levels than the reference group. Overall, from baseline (months 1–3) to months 8–9, there was an increase in the percentage of patients using a P binder (35.0% to 51.7%), an increase in the percentage of days a P binder was used (30.9% to 50.0%), but little change in mean serum P (5.2 mg/dL [1.67 mmol/L] to 5.3 mg/dL [1.71 mmol/L]). Compared with baseline (months 1–3), mean serum P increased by months 8–9 in groups CH (6.6 mg/dL [2.12 mmol/L] to 7.5 mg/dL [2.41 mmol/L]) and TH (5.4 mg/dL [1.73 mmol/L] to 5.6 mg/dL [1.81 mmol/L]) and decreased in other groups. Conclusions: Serum P can be difficult to control following initiation of HD, as shown by the small proportion of patients with levels in the target range. The majority of patients had elevated levels of serum P, despite higher levels of binder usage, and were younger with a higher incidence of elevated PTH than the reference group. Increases in binder usage over time were seen, but rates were lower than observed in other studies. These findings may indicate that dietary education and more aggressive use of the most effective P binders may be needed to improve P management. SAP552 LOWER SERUM PHOSPHORUS CAN BE ATTAINED BY INCREASING THE DOSE OF LANTHANUM CARBONATE Rosamund Wilson Rosamund Wilson 1Spica Consultants, Marlborough, UK J. Brian Copley J. Brian Copley 2Shire Pharmaceuticals, Wayne, Pa, USA Lynne Poole Lynne Poole 3Shire Pharmaceuticals, Basingstoke, UK Abstract Introduction and Aims: Patients with chronic kidney disease experiencing hyperphosphataemia should be treated with a dose of phosphate binder that is titrated to achieve recommended target levels of serum phosphorus. However controlling serum phosphorus to these levels is challenging. The objective of this analysis was to investigate whether patients had better control of serum phosphorus on a dose of 3000 mg/day of lanthanum carbonate compared with lower doses. Methods: Data were analysed, post hoc, from a European, randomized, controlled study of haemodialysis patients receiving lanthanum carbonate or calcium carbonate. Patients entered a 5-week dose titration period during which doses were adjusted to achieve serum phosphorus control ( = 5.6 mg/dL). After the titration period, patients with controlled serum phosphorus entered a 20-week maintenance period. Patients randomized to lanthanum carbonate, who entered the maintenance period on a dose of < 3000 mg/day lanthanum carbonate, and subsequently increased their dose to 3000 mg/day, were analysed to evaluate whether increasing the dose had any positive effect on serum phosphorus levels. New or worsening adverse events reported by these patients during the maintenance period were also examined. Results: During the maintenance period, 35 patients who entered on 1500 or 2250 mg/day lanthanum carbonate had their dose increased to 3000 mg/day. On average these patients had serum phosphorus levels approximately 0.6 mg/dL lower on 3000 mg/day of lanthanum carbonate compared with doses = 2250 mg/day. Sixty-six percent of patients (23/35) had better serum phosphorus control on 3000 mg/day than on lower doses. Eighty-six percent (30/35) of patients experienced AEs on any dose of lanthanum carbonate, and new or worsening adverse events (AEs) were experienced by 74% (26/35) whilst on or following a dose of 3000mg. The majority were mild (12) or moderate (13). Consistent with previous studies evaluating lanthanum carbonate, the most common AEs observed were gastrointestinal in nature: 17 (49%) patients experienced gastrointestinal AEs of mild (9) or moderate (8) intensity. Conclusions: Serum phosphorus control may be improved by increasing the dose of phosphate binders. This exploratory analysis suggests that increasing lanthanum carbonate to 3000 mg/day may help to reduce serum phosphorus levels and may improve the percentage of patients achieving target levels. In addition the new or worsening adverse events observed were similar in nature and frequency to previous studies. Lanthanum carbonate has been shown to be well tolerated when given at doses up to 4500 mg/day in patients with chronic kidney disease receiving haemodialysis. SAP553 INCREASED LEVELS OF SERUM PARATHYROID HORMONE AND FIBROBLAST GROWTH FACTOR-23 ARE THE MAIN FACTORS ASSOCIATED WITH THE PROGRESSION OF VASCULAR CALCIFICATION IN LONG- HOUR HEMODIALYSIS PATIENTS Guillaume Jean Guillaume Jean 1Nephrocare Tassin-Charcot France Eric Bresson Eric Bresson 2Clinique Protestante Caluire France Charles Chazot Charles Chazot 3Nephrocate Tassin-Charcot France Abstract Introduction and Aims: Vascular calcifications (VCs) have been frequently observed in chronic kidney disease (CKD), especially in hemodialysis (HD) patients, and reflect more severe cardiovascular disease. The aim of the present study was to assess the frequency and the factors associated with the progression of VCs using a semi-quantitative X-ray score. Methods: We included all prevalent HD patients with initial radiological scores ranging from 0 to 3 according to the severity of the VCs. Patients were classified as non-progressors or progressors after 3 years. We analysed the values of the means of all biological data and treatment doses. Results: Among the 85 patients, 44.7% were classified as progressors. Only exhibiting high levels of serum iPTH ( > 190 pg/ml) and fibroblast growth factor (FGF)-23 levels ( > 3000 RU/ml) is associated with the risk for VC progression (odds ratio, 5.8; 1.7–19.8, P = 0.004). Calcitriol analogs (38%), cinacalcet (15%), dialysate calcium (mean 1.48 mmol/l), dialysis session time (4 hr to 8 hr) and calcium- (10%) and non-calcium based phosphate binders (38%) were prescribed on an individual basis. Hyperphosphatemia ( < 10%), and especially, hypercalcemia (1%), and hyperparathyroidism (HPT > 585 pg/ml = 0%) were infrequently observed. Conclusions: The main factor associated with VC progression was the association of higher serum PTH and FGF-23 levels. It remains to be seen whether patients should be treated to lower their PTH value, even in the target range, using calcitriol analogs, calcimimetics, parathyroidectomy, or by modifying the Klotho-FGF-23 axis. SAP554 BIOLOGICAL IMPACT OF TARGETED DIALYSATE CALCIUM CHANGES IN HEMODIALYSIS PATIENTS: THE KEY ROLE OF PARATHYROID HORMONE Guillaume Jean Guillaume Jean 1Nephrocare Tassin-Charcot France Charles Chazot Charles Chazot 2Nephrocate Tassin-Charcot France Abstract Introduction and Aims: The quest for an optimal dialysate calcium (DCa) concentration is a crucial aspect in hemodialysis (HD) patients. DCa individualization has been advocated, but most dialysis centers use a fixed DCa, preferably 1.25 mmol/l in the US and 1.5 mmol/l in European countries. The aim of the present study was to assess the short-term biological impact of individualized DCa prescription to maintain normal serum calcium and serum parathyroid hormone (PTH) between 150 and 300 pg/ml. Methods: Between January 2008 and December 2010, all prevalent patients were checked for the need for DCa change according to our usual strategy. Baseline values (T0) and values after 3 months (T3) were compared for serum calcium, phosphate, total alkaline phosphatases (t- ALP), and PTH. Results: Seventy-eight patients were retained for analysis with only 1 DCa change. Doses of vitamin D derivates, oral calcium, and cinacalcet were kept constant. Increasing the DCa from 1.25 to 1.5 mmol/l and from 1.5 to 1.75 mmol/l resulted in a significant increase of calcemia ( + 2.2% and + 1.7%) and a decrease of phosphatemia (-7% and -9%), t-ALP (-10 and -12%), and PTH (-50% and -62%). Decreasing DCa from 1.75 to 1.5 and from 1.5 to 1.25 mmol/l resulted in a decrease of calcemia (-2.5% and -1.7%) and an increase of phosphatemia ( + 11% and + 12%), t-ALP ( + 12% and + 10%), and PTH ( + 138% and + 175%). Conclusions: DCa individualization has a significant impact on mineral metabolism parameters, especially on serum PTH levels and could be considered as an additional therapy in a more global strategy, together with the prescription of phosphate binders, vitamin D, and calcimimetics. SAP555 DIALYSATE CALCIUM INDIVIDUALIZATION ADJUSTED BY INTRADIALYTIC CALCIUM BALANCE Francisco Maduell Francisco Maduell 1Hospital Clinic, Barcelona, Spain Francisco Maduell Francisco Maduell 1Hospital Clinic, Barcelona, Spain Marta Arias Marta Arias 1Hospital Clinic, Barcelona, Spain Alexis Sentis Alexis Sentis 1Hospital Clinic, Barcelona, Spain Nestor Rodriguez Nestor Rodriguez 1Hospital Clinic, Barcelona, Spain Sonia Jimenez Sonia Jimenez 1Hospital Clinic, Barcelona, Spain Belen Alemany Belen Alemany 2Hospital Dr. Peset, Valencia, Spain Nuria Perez Nuria Perez 1Hospital Clinic, Barcelona, Spain Manel Vera Manel Vera 1Hospital Clinic, Barcelona, Spain Nestor Fontsere Nestor Fontsere 1Hospital Clinic, Barcelona, Spain Montserrat Carrera Montserrat Carrera 1Hospital Clinic, Barcelona, Spain Aleix Cases Aleix Cases 1Hospital Clinic, Barcelona, Spain Abstract Introduction and Aims: The relationship of serum calcium with cardiovascular risk as well as the introduction of non- calcium-based phosphate binders and calcimimetics, have changed the setting for the pre- dialysis serum calcium in recent years from 9.5-10.5 mg/dl to 8.5-9.5 mg/dl. To assess more accurately the changes in calcium (Ca) during hemodialysis (HD) sessions and individualize the prescription, the aim of this study was to assess the intradialytic balance comparing dialysate Ca concentrations. Methods: Prospective study in 98 patients, 68 men and 30 women, 59.3 ± 15 years, regular dialysis program. Each patient received two HD sessions with two different dialysate Ca concentrations: 2.5 (CA25) or 3.0 (CA30) mEq/L. The remaining dialysis parameters did not change: dialysis monitor, dialysis time, blood flow and dialysis flow rate. Pre- and post- dialysis Ca, phosphorus (P) and PTH were determined and calcimimetics, paricalcitol and calcium-based phosphate binders were recordedv Results: There were no differences in pre-dialysis values of Ca, 8.81 ± 0.65 (CA25) and 8.88 ± 0.61 (CA30), P, 4.00 ± 1.01 (CA25) and 4.19 ± 1.2 (CA30), and PTH, 352 ± 288 (CA25) and 369 ± 310 (CA30). Post-dialysis Ca and PTH did not change significantly with CA25 dialysate while there was a significant post-dialysis Ca increase to 10.17 ± 0.6 (p < 0.001) accompanied by a decrease in post-dialysis PTH (181 ± 227, p < 0.001) with CA30. However, with CA25 dialysate, different subgroups of Ca pre-dialysis were analyzed, ( < 8.5 mg/dl (30.6%), 8.5-9.0 (31.6%), 9.1-9.5 (23.5%) and > 9.5 mg/dl (14.3%) and a positive Ca balance during the session was appreciated in the < 8.5 (p < 0.001) and 8.5-9.0 (p < 0.01) subgroups , neutral in 9.1-9.5 and negative when the initial Ca values were > 9.5 mg/dL (p < 0.01). A positive Ca balance (p < 0.001) and a negative PTH balance (p < 0.01) were observed in all subgroups with CA30 dialysate. 42% of patients were taking calcimimetics, 47% paricalcitol and 32% calcium-based phosphate binders, without linking these drugs with the pre-and post-dialysis Ca behavior studied with both dialysates. Conclusions: The prescription of Ca dialysate needs an individualization based on pre- and post-dialysis Ca values and the need for a positive, neutral or negative balance in relation to the phospho- calcium metabolism of the patient for a proper control of the calcifications. SAP556 INTRADIALYTIC CALCIUM BALANCE IN HEMODIALYSIS PATIENTS TREATED WITH CALCIMIMETICS AND SEVELAMER HYDROCHLORIDE Makrouhi Sonikian Makrouhi Sonikian 1A. Fleming General Hospital Theodora Miha Theodora Miha 2Nephrology Department, A. Fleming General Hospital, Athens, Greece; Iakovos Skarakis Iakovos Skarakis 3Chemistry School, Kapodistriakon University, Athens, Greece Ioannis Karatzas Ioannis Karatzas 4Biochemistry Department, A. Fleming General Hospital, Athens, Greece; Aphroditi Karaitianou Aphroditi Karaitianou 5Biochemistry Department, A. Fleming General Hospital, Athens, Greece Abstract Introduction and Aims: After calcium-free phosphate binder and calcimimetic introduction in nephrologists' therapeutic armamentarium dialysate calcium concentration (DCa) was empirically increased with the intention of avoiding probable hypocalcemia. However, calcium balance during hemodialysis (HD) session has not been studied under this combined treatment. We investigated intradialytic calcium (Ca) balance under calcium-free phosphate binders combined or not with calcimimetics. Methods: Ten stable anuric hemodialyzed individuals, with no access recirculation, aged 62(38-80) years, on HD thrice weekly since 68(24-257) months were studied and classified in two groups A (GA) and B (GB) including 5 patients each. All patients were under sevelamer hydrochloride as a phosphate binder and no patient under vitamin D/vitamin D analog. Secondary hyperparathyroidism was present only in GA patients who were treated with cinacalcet. All patients were submitted in 4-hour sessions of standard HD with low flux polysulfone membranes, blood flow rate of 300ml/min, dialysate flow rate of 600ml/min and a DCa of 3,2mEq/l (6,4mg/dl). Blood samples were collected from “arterial lines” of the extracorporeal circuit as well as sixty milliliters of dialysis fluid (D) at the effluent dialyser port at baseline, every hour and at the end of the sessions. Paired “arterial” and “venous” blood samples were drawn simultaneously at two hours. Results: No difference between groups was observed in Kt/V values and in pre-dialysis hematocrit, serum albumin, phosphate, magnesium, sodium, potassium and bicarbonate levels. Pre-dialysis serum calcium corrected for albumin levels (sCa) were lower in GA compared with GB (8,5 ± 0,4 vs 9,5 ± 0,6mg/dl-p = 0,02) and increased at the end of sessions in both groups (GA: to 11,1 ± 0,2mg/dl-p = 0,04, GB: to 10,9 ± 1,2-p = 0,04). At two hours sCa was higher at the dialyser venous limb compared with arterial limb in both groups (G?:10,5 ± 0,6 to 11,7 ± 0,6- p = 0,04, GB:10,7 ± 1,4 to 11,7 ± 0,7-p = 0,04), with negative values of transmembrane clearance in all patients suggesting Ca transfer from dialysate to blood. Ca mass excreted into dialysate was greater in GB compared to GA (9022,2 ± 453,2 vs 8447,02 ± 238,6mg-p = 0,03) and correlated negatively to excreted masses of phosphate (R = −0,71-p = 0,02), magnesium (R = - 0,73 -p = 0,02) and sodium (R = −0,84 –p = 0,001). Intradialytic Ca balance was positive in both groups but especially in GA ( + 768,97 ± 238,62 vs + 113,8 ± 374,95mg-p = 0,02). Conclusions: DCa of 3,2mEq/l leads to a positive intradialytic Ca balance, more important at low pre- dialysis sCa levels, which must be taken into account for patients under calcimimetics and calcium-free phosphate binders and especially in those with extraskeletal calcifications. SAP557 LOW VS STANDARD CALCIUM DIALYSATE IN TREATMENT OF HAEMODIALYSIS PATIENTS WITH DIFFERENT SERUM PARATHYROID HORMONE LEVELS Vasilije Tomanoski Vasilije Tomanoski 1Special Hospital of Haemodialysis Fresenius Medical Care, Novi Sad, Serbia Dobrila Petkovic Dobrila Petkovic 1Special Hospital of Haemodialysis Fresenius Medical Care, Novi Sad, Serbia Ivan Curic Ivan Curic 1Special Hospital of Haemodialysis Fresenius Medical Care, Novi Sad, Serbia Rajko Hrvacevic Rajko Hrvacevic 2Fresenius Medical Care Srbija D.O.O., Belgrade, Serbia Abstract Introduction and Aims: In patients undergoing haemodialysis (HD) low calcium (Ca) dialysate has been proposed as the first choice for a better control of renal bone disease, particularly in patients with low bone turnover with serum parathyroid (PTH) level under 120 pg/mL. Methods: Eighty patients, 35F and 45M, with the average age 57,5 ± 14,4 years and HD duration 45,2 ± 43,5 months were included in the study. Patients with surgical parathyroidectomy during the observation period were excluded from the study. Based on serum PTH levels two groups of patients were formed. LCD (low Ca dialysate) group, n = 19 patients, with PTH levels under 120 pg/ml were on HD with Ca dialysate 1,25 or 1,125 mmol/L and SCD (standard Ca dialysate) group, n = 61 patients, with PTH levels over 120 pg/ml were on HD with Ca dialysate 1,5 mmol/L for a period of 12 months. Clinical data (age, sex, haemodialysis duration, presence of diabetes mellitus (DM), the average daily dose of calcium-carbonate and weekly of vitamin D) were compared between the two groups. Biochemical data (serum PTH level, total serum Ca and inorganic phosphorus) were evaluated every 6 months. Statistical analyses were performed using SPSS for Windows. Results: At the start of the observation period between the two groups there were statistically significant differences in regard of following clinical and biochemical data: predominance of male sex (LCD group: 73,7 % male sex vs. SCD group: 50,8 %, p = 0.067), presence of diabetes mellitus (LCD group: 31,6 % of patients with DM vs. SCD group: 11,5 % with DM, p = 0.048), the average weekly dose of vitamin D (LCD group: 0,35 ± 0,38 μg/w vs. SCD group: 1,31 ± 1,22, p = 0.001), serum PTH level (LCD group: 60,5 ± 27,4 pg/mL vs. SCD group: 364 ± 352, p < 0.001) and serum total Ca (LCD group: 2,40 ± 0,2 mmol/L vs. SCD group: 2,23 ± 0,19, p = 0.002). Comparison between LCD and SCD groups by combined analysis of variance with repeated measures showed an increase in serum PTH levels starting of month 6 in the LCD group, while the serum PTH levels in the SCD group did not change significantly (LCD group: PTH 0m = 60,5 ± 27,4 pg/mL, PTH 6m = 93,4 ± 46,8, PTH 12m = 179,6 ± 84,1 vs. SCD group: PTH 0m = 364 ± 352 pg/mL, PTH 6m = 266 ± 329, PTH 12m = 341 ± 409, p = 0.006). Serum total Ca significantly increased in SCD group, while in LCD group decreased but not significantly. Serum phosphorus levels did not change significantly in both groups. Conclusions: Use of LCD for 1 year in patients with low serum PTH levels was associated with a significant increase in serum PTH levels. In SCD group there was significant increase in serum total calcium. SAP558 CINACALCET VS. PARICALCITOL IN HEMODIALYSIS PATIENTS Nickos Kaperonis Nickos Kaperonis 1Red Cross Hospital, Athens, Greece Christine Kourvelou Christine Kourvelou 1Red Cross Hospital, Athens, Greece Aris Sgantzos Aris Sgantzos 1Red Cross Hospital, Athens, Greece Dimitra Nastou Dimitra Nastou 1Red Cross Hospital, Athens, Greece George Ntatsis George Ntatsis 1Red Cross Hospital, Athens, Greece Stavroula Ziakka Stavroula Ziakka 1Red Cross Hospital, Athens, Greece Filippos Karakasis Filippos Karakasis 1Red Cross Hospital, Athens, Greece Vasileios Nikolopoulos Vasileios Nikolopoulos 1Red Cross Hospital, Athens, Greece Dimitra Zoubaniotou Dimitra Zoubaniotou 1Red Cross Hospital, Athens, Greece Alexandra Koutsovasili Alexandra Koutsovasili 1Red Cross Hospital, Athens, Greece Antonis Zagorianakos Antonis Zagorianakos 1Red Cross Hospital, Athens, Greece Vasileios Kolovos Vasileios Kolovos 1Red Cross Hospital, Athens, Greece Nikos Papagalanis Nikos Papagalanis 1Red Cross Hospital, Athens, Greece Abstract Introduction and Aims: Calcimimetics as well as vitamin D analogs are used for the treatment of secondary hyperparathyroidism in end-stage renal disease. We aimed to compare the effects of cinacalcet to paricalcitol in patients on hemodialysis therapy. Methods: Thirteen patients (11M, 2F) with mean age 57 (range 38-76) years old, on dialysis for 24.3 ± 35.8 months, received in a cross-over design cinacalcet (p.o) and paricalcitol (i.v), each for 6 months separated by a 2-months washout period. Serum parathyroid hormone (PTH), calcium (Ca) and phosphate (P) were measured every month during the study period, when dose adjustment of either cinacalcet or paricalcitol took place–if necessary- for achievement / maintenance of PTH goal levels ( < 300 pg/ml). At the end of the study, mean dose of cinacalcet the patients had received was 40.4 mg per day and that of paricalcitol 13.2 mcg per week. We use Repeated Measures Analysis of Variance to estimate the effects of two regimens on the above parameters, including possible interaction between treatment and time. Results: During treatment with cinacalcet, PTH (P = 0.005) and Ca (P = 0.01) concentrations proved to be lower than treatment with paricalcitol. These differences reached statistical significance in the last two months for PTH and from the 3rd month until the end for Ca (Table, mean values of PTH, pg/ml and Ca, mg/dl).3 Table 1.     Regarding these effects, the multivariate tests for repeated measure of the interaction between treatment and time failed to achieve a significant level (P = 0.08). Although P concentrations (as well as CaxP product) were also lower with cinacalcet, the whole analysis showed that the impact of medications on P did not differ significantly. Conclusions: Cinacalcet may be more effective than paricalcitol in the treatment of secondary hyperparathyroidism in dialysis patients. This is further emphasized by the hypocalcemic action of cinacalcet, which may be beneficial against the risk of vascular calcification. SAP559 AN INTEGRATED CARE APPROACH USING ELECTRONIC PILLBOX MONITORING OF CINACALCET TO REACH IPTH TARGETS IN HEMODIALYSIS PATIENTS: A MULTICENTER, RANDOMIZED TRIAL Valentina Forni Valentina Forni 1University Hospital of Lausanne, Lausanne Menno Pruijm Menno Pruijm 2University Hospital Lausanne, Lausanne Menno Pruijm Menno Pruijm 1University Hospital of Lausanne, Lausanne Eric Tousset Eric Tousset 1University Hospital of Lausanne, Lausanne Carole Zweiacker Carole Zweiacker 1University Hospital of Lausanne, Lausanne Isabel Menetrey Isabel Menetrey 1University Hospital of Lausanne, Lausanne Lorenzo Berwert Lorenzo Berwert 1University Hospital of Lausanne, Lausanne Roberto Bullani Roberto Bullani 1University Hospital of Lausanne, Lausanne Anne Cherpillod Anne Cherpillod 1University Hospital of Lausanne, Lausanne Luca Gabutti Luca Gabutti 1University Hospital of Lausanne, Lausanne Thierry Gauthier Thierry Gauthier 1University Hospital of Lausanne, Lausanne Georges Halabi Georges Halabi 1University Hospital of Lausanne, Lausanne Claudine Mathieu Claudine Mathieu 1University Hospital of Lausanne, Lausanne Pascal Meier Pascal Meier 1University Hospital of Lausanne, Lausanne Olivier Phan Olivier Phan 1University Hospital of Lausanne, Lausanne Silvio Pianca Silvio Pianca 1University Hospital of Lausanne, Lausanne Carlo Schoenholzer Carlo Schoenholzer 1University Hospital of Lausanne, Lausanne Daniel Teta Daniel Teta 1University Hospital of Lausanne, Lausanne Beat Von Albertini Beat Von Albertini 1University Hospital of Lausanne, Lausanne Bernard Vrijens Bernard Vrijens 1University Hospital of Lausanne, Lausanne Michel Burnier Michel Burnier 1University Hospital of Lausanne, Lausanne Abstract Introduction and Aims: Controlling secondary hyperparathyroidism in hemodialysis-patients is often a cumbersome task, partly due to patient's non-adherence to prescribed drugs. Electronic pillbox monitoring (MEMS) is a strong tool to unmask non-adherence, but it is actually unknown whether monitoring of adherence can help nephrologists to achieve their pre-defined iPTH-targets. The aim of this study was to assess whether an integrated care approach (IC), using cinacalcet adhesion data for dose prescription, leads to lower iPTH values and/or higher percentage of patients on iPTH target, as compared to a usual care approach (UC). Methods: This is a multi-center study including patients on chronic hemodialysis receiving a stable dose of cinacalcet for at least 1 month. Patients were randomized either to the usual care strategy (UC) in which no cinacalcet adherence data were available, or to an Integrated Care (IC) approach which implied monitoring of drug adherence before deciding on any change in cinacalcet doses. Adherence to cinacalcet was monitored in all patients by MEMS during a six month period, but adherence data were blinded in the UC group. The monitoring period was followed by 3 months period without adhesion monitoring. iPTH, phosphate, and calcium targets, as well as the prescription of additional drugs were left to the discretion of the physician. Results: 50 patients were enrolled and 41 were analyzed for the 6 month data. There were no significant difference in serum phosphate, total calcium, Vitamin D and phosphate binder between the groups at baseline and 6 months. In the UC group, we observed a slight increase in iPTH ( + 113 ng/l) with time, whether in the IC group iPTH significantly decreased (- 94 ng/l, p = 0.02) (δiPTH p = 0.009 IC vs. UC, table). The mean adhesion declined in the UC group (-5%), however improved in the IC group ( + 11%) (p = 0 = 02). The mean dose of cinacalcet was not significantly higher in the IC group at baseline and 6 months. Conclusions: The use of drug adherence monitoring in hemodialysis patients receiving cinacalcet enables to improve drug adhesion and to increase the percentage of patients on iPTH target, but not at the prize of a lower cinacalcet dose.4 Table 1.     Values are shown as mean ± SD or median (iqr), as appropriate;* Wilcoxon rank sum test, ** Wilcoxon matched-pairs signed-rank test SAP560 CONSISTENT USE OF CINACALCET IMPROVES CLINICAL OUTCOMES IN JAPANESE HAEMODIALYSIS PATIENTS WITH SECONDARY HYPERPARATHYROIDISM: MARGINAL STRUCTURAL ANALYSES FROM THE MINERAL AND BONE DISORDER OUTCOMES STUDY FOR JAPANESE CKD STAGE 5D PATIENTS (MBD-5D) Tadao Akizawa Tadao Akizawa 1Department of Nephrology, Showa University School of Medicine, Tokyo, Japan Tadao Akizawa Tadao Akizawa 1Department of Nephrology, Showa University School of Medicine, Tokyo, Japan Tadao Akizawa Tadao Akizawa 1Department of Nephrology, Showa University School of Medicine, Tokyo, Japan Noriaki Kurita Noriaki Kurita 2Kyoto University, Kyoto, Japan Masahide Mizobuchi Masahide Mizobuchi 1Department of Nephrology, Showa University School of Medicine, Tokyo, Japan Masafumi Fukagawa Masafumi Fukagawa 3Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan Yoshihiro Onishi Yoshihiro Onishi 4Institute for Health Outcomes and Process Evaluation Research Takuhiro Yamaguchi Takuhiro Yamaguchi 5Tohoku University, Sendai, Japan Takeshi Hasegawa Takeshi Hasegawa 6Showa University Fujigaoka Hospital Shingo Fukuma Shingo Fukuma 2Kyoto University, Kyoto, Japan Kiyoshi Kurokawa Kiyoshi Kurokawa 7National Graduate Institute for Policy Studies Shunichi Fukuhara Shunichi Fukuhara 2Kyoto University, Kyoto, Japan Abstract Introduction and Aims: A few observational studies suggest the possible association of cinacalcet (CC) use and decreased mortality in haemodialysis (HD) patients with secondary hyperparathyroidism (SHPT) who are treated with vitamin D receptor activator (VDRA). However, the question of whether consistent use of CC improves clinical outcomes in real-world settings remains to be clarified. Methods: This is a planned analysis of the MBD-5D, a 3-year case-cohort study involving 86 HD facilities in Japan. Eligible patients consisted of all HD patients with SHPT in these facilities (n = 8229). We examined the relationship between CC use and each of 3 clinical outcomes: (1) mortality; (2) cardiovascular (CV) mortality; and (3) mortality or CV hospitalization. Marginal structural model analyses were performed to estimate the effects of consistent CC use and to adjust for time-dependent confounding, such as serum calcium and PTH, which are possible prognostic factors and are also affected by previous CC use. Subgroup analyses stratified by VDRA use at baseline were also examined. Results: At baseline, 49% of patients were treated with injectable VDRA, 29% with oral VDRA, and 22% were not treated with any VDRA. Of all patients, 15% died, 6% experienced CVD death, and 32% experienced death or CV hospitalization. In the total population, consistent CC use was associated with decreases in all three clinical outcomes by approximately 30% [Table]. Subgroup analyses showed similar trends to decreased mortality among the three groups, but consistent CC use was associated with a greater decrease in mortality with non-VDRA than with any VDRA. Conclusions: Consistent CC use may improve clinical outcomes of HD patients with SHPT. Footnotes: Equal contribution (T.A. and N.K.).5 Table 1 Relationships between cinacalcet use and clinical outcomesa     HR: hazard ratio, CI: confidence interval. aTime-dependent confounders (calcium, phosphorus, PTH, VDRA, phosphate binder, albumin, and BMI) and baseline confounders (age, sex, vintage, primary renal disease, CV morbidity, and number of non-CV morbidities) were adjusted. bEstimates derived from case-cohort participants. The others were derived from subcohort participants (n = 3276). SAP561 IMPROVED CONTROL OF SECONDARY HYPERPARATHYROIDISM (SHPT) USING CINACALCET WITH LOW DOSES OF VITAMIN D (IF PRESCRIBED) IN INCIDENT HAEMODIALYSIS SUBJECTS NOT RECEIVING VITAMIN D AT ENROLMENT P Urena P Urena 1Clinique Du Landy, France P Urena P Urena 1Clinique Du Landy, France I Bridges I Bridges 2Amgen Ltd, UK C Christiano C Christiano 3East Carolina University, USA S Cournoyer S Cournoyer 4Hôpital Charles Lemoyne, Canada K Cooper K Cooper 5Amgen Inc., USA M Farouk M Farouk 6Amgen (Europe) Gmbh, Switzerland N Kopyt N Kopyt 7Lehigh Valley Hospital, USA M Rodriguez M Rodriguez 8Hospital Universitario Reina Sofia. Imibic, Spain D Zehnder D Zehnder 9Warwick Medical School, UK A Covic A Covic 10Parhon University Hospital, Gr.T. Popa University of Medicine and Pharmacy, Romania Abstract Introduction and Aims: Incident dialysis patients have a high prevalence of SHPT; initial treatment typically includes vitamin D sterols (vitD) and phosphate binders. Cinacalcet therapy is commonly used later in the disease course in patients who are not adequately controlled with vitD. This study evaluated the efficacy of cinacalcet with low-dose vitD, if prescribed, in incident haemodialysis patients. In the whole cohort (N=309), cinacalcet with low-dose vitD, if prescribed, provided a more effective treatment approach than flexible doses of vitD alone (control) for SHPT, regardless of disease severity (Urena et al, ASN 2011). We report the efficacy of cinacalcet with low-dose vitD, if prescribed, in the subgroup of subjects not receiving vitD at enrolment. Methods: Subjects with SHPT (PTH > 31.8 pmol/L) on dialysis for > 3–12 months were randomized 1:1 to cinacalcet (+2.0 μg IV paricalcitol or equivalent per dialysis session, if prescribed) or vitD (if prescribed) alone (control). Randomization was stratified by PTH at screening (31.8–47.7, > 47.7–63.7 and > 63.7 pmol/L). Total treatment duration was 12 months, with primary efficacy endpoint ( ≥ 30% PTH reduction vs baseline) assessed at 6 months. 161 subjects not receiving vitD for = 30 days prior to enrolment were included in this analysis (cinacalcet n = 82, control n = 79), irrespective of on-study vitD use. Results: Baseline characteristics were well balanced. Mean ± SD dialysis vintage at enrolment in the cinacalcet and control groups was 7.1 ± 2.7 and 7.1 ± 2.9 months. Fewer subjects in the cinacalcet than control group received vitD during the study (48, 59% vs 62, 78%), with mean study vitD dose (including 0 doses) of 3.3 ± 4.9 and 9.4 ± 8.8 μg/wk, respectively. Mean cinacalcet dose was 36 ± 25 mg/d overall and increased across PTH strata (28 ± 19, 35 ± 27, 48 ± 27 mg/d, respectively). A greater proportion of subjects achieved the primary endpoint in the cinacalcet (70%) than control group (44%; p = 0.001); a similar difference was observed at 12 months (72% vs 56%; p = 0.032). Achievement of the primary endpoint was greater in cinacalcet-treated subjects across all PTH strata. PTH was lower in the cinacalcet than control group at 6 months (adjusted mean (95% confidence interval): 28.5 (25.1, 32.4) pmol/L vs 39.9 (35.0, 45.5) pmol/L; p < 0.001) and 12 months (28.0 (24.0, 32.6) pmol/L vs 35.4 (30.3, 41.4) pmol/L; p = 0.031). 12 cinacalcet and 3 control subjects had PTH oversuppression ( < 15.9 pmol/L) at 6 months. A greater proportion of patients in the cinacalcet than control group experienced hypocalcaemia (defined as = 1.88 mmol/L; 33% vs 6%); most incidences in the cinacalcet group occurred during the titration phase. Conclusions: As reported for the entire cohort, this subgroup analysis of subjects not on vitD at enrolment indicates that cinacalcet with low-dose vitD, if prescribed, provides a more effective treatment approach for SHPT than vitD, if prescribed, without cinacalcet in incident dialysis patients. SAP562 CINACALCET HCL INDUCES DIFFICULTY OF PARATHYROIDECTOMY FOR PATIENTS WITH SECONDARY HYPERPARATHYROIDISM Yoshihiro Tominaga Yoshihiro Tominaga 1Nagoya Second Red Cross Hospital, Nagoya Japan Takahisa Hiramitsu Takahisa Hiramitsu 2Nagoya Second Red Cross Hospital, Nagoya, Japan Takayuki Yamamoto Takayuki Yamamoto 2Nagoya Second Red Cross Hospital, Nagoya, Japan Kouji Nanmoku Kouji Nanmoku 2Nagoya Second Red Cross Hospital, Nagoya, Japan Yoshiko Matsuda Yoshiko Matsuda 2Nagoya Second Red Cross Hospital, Nagoya, Japan Toyonori Tsuzuki Toyonori Tsuzuki 2Nagoya Second Red Cross Hospital, Nagoya, Japan Abstract Introduction and Aims: Cinacalcet HCl (Cinacalcet) dramatically suppresses PTH secretion and reduces the frequency of parathyroidctomy (PTx) for patients with secondary hyperparathyroidism (SHPT). However, remarkably advanced SHPT is resistant to Cinacalcet and some patients can not tolerate GI symptoms induced by Cinacalcet. PTx is required in these patients. We evaluated histopathological findings of parathyroid glands which were removed by PTx after exposure of Cinacalcet and influence to the operation. Methods: Initial PTx for SHPT was performed between January 2009 and December 2010, totally in 124 patients in our department. Our operative procedure is total PTx with forearm autograft. Cinacalcet was not administered in 74 patients before PTx (non exposure (NE) group) and taken in 50 patients (exposure (E) group). We evaluated total glandular weight, weight of largest gland/ total weight ratio, histopathological findings by usual HE stain, number of removed glands and incidence of adhesion of parathyroid gland to surrounding tissue. Results: Serum PTH levels significantly lower in group E than in group NE (602 vs 832 pg/mL), however total glandular weight was larger in group E than in group NE (2206 vs 1586 mg) and largest/total weight ratio was significantly higher in group E than in group NE (0.53 vs 0.48). Asymmetric enlargement was clearer in Cinacalcet exposure group, and the incidence of fewer than 3 glands resected at PTx was more frequent in group E than in group NE (16.0% vs 9.5%).Fibrous degeneration, hemorrhagic infarction, deposition of hemosiderin and cystic and follicular degeneration significantly were more frequently detected in group E than in group EN. In group N adhesion of parathyroid gland surrounding tissue including recurrent laryngeal nerve more frequently identified than in group EN. Conclusions: Cinacalcet might induce asymmetric enlargement, fibrous degeneration and hemorrhagic infarction of parathyroid glands that might influence detection of all parathyroid glands and injury of recurrent laryngeal nerve. PTx should be recommended especially in patients with advanced SHPT in whom long-survival is expected. SAP563 ACTIVATED VITAMIN D ALTERS THE T CELL DIFFERENTIATION IN CHRONIC HEMODIALYSIS PATIENTS WITH SECONDARY HYPERPARATHYROIDISM Cheng-Lin Lang Cheng-Lin Lang 1Department of Internal Medicine, Cardinal Tien Hospital, Yong He Br Kuo-Cheng Lu Kuo-Cheng Lu 2Department of Internal Medicine, Cardinal Tien Hospital Min-Hui Wang Min-Hui Wang 2Department of Internal Medicine, Cardinal Tien Hospital Shin-Yun Liu Shin-Yun Liu 3Department of Internal Medicine, National Taiwan University Hospital Jenq-Wen Huang Jenq-Wen Huang 3Department of Internal Medicine, National Taiwan University Hospital Chih-Kang Chiang Chih-Kang Chiang 3Department of Internal Medicine, National Taiwan University Hospital Kuan-Yu Hung Kuan-Yu Hung 3Department of Internal Medicine, National Taiwan University Hospital Abstract Introduction and Aims: Patients on chronic hemodialysis (HD) are impaired in their immune response, including cellular and humoral immunity. Activated vitamin D is widely used in HD patients with secondary hyperparathyroidism (SHPT), and is a well-known immunomodulatory agent. We investigated the relationship between serum 25-hydroxyvitamin D (25(OH)D) level, T cell cytokines, and T cell differentiation in HD patients, and their immune response after treatment with activated vitamin D for 3 months. Methods: In total, 57 patients on chronic HD were enrolled. Peripheral blood mononuclear cells were cultured and stimulated by mitogens, then analyzed by flow cytometry. The serum 25(OH)D level and levels of T helper-1 (Th1) and Th2 cytokines in the sera and culture supernatant were detected by enzyme-linked immunosorbent assay. We analyzed the results after HD patients with secondary hyperparathyroidism had been treated with activated vitamin D for three months. Results: In total, 35 patients were vitamin D deficient at baseline (serum 25(OH)D level < 20 ng/ml). Compared with non-vitamin D deficient patients, they had lower Th2 cytokine in the sera (p < 0.01) and in the culture supernatant (p < 0.001). Their T cell differentiation tended more toward the Th1 type than Th2 type (p < 0.001). After SHPT patients had been treated with activated vitamin D, the level of Th1 cytokines decreased while the Th2 cytokine level increased, in both the sera and the culture supernatant (p < 0.05). The T cell differentiation tended toward the Th2 type (p = 0.027) Conclusions: T-cell differentiation correlated only with serum 25(OH)D level. The higher the vitamin D in the sera, the more prevalent was Th2 cytokines and Th2 differentiation. Treatment with activated vitamin D influenced T cell differentiation and cytokine expression in SHPT patients. SAP564 TWO YEARS AFTER THE PUBLICATION OF THE K/DIGO CKD-MBD GUIDELINES: WHAT DID CHANGE IN OUR TREATMENT STRATEGIES? Christos Bantis Christos Bantis 1Department of Nephrology, Papanikolaou General Hospital, Thessaloniki, Greece Nicoletta-Maria Kouri Nicoletta-Maria Kouri 2Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece Ellada Tsandekidou Ellada Tsandekidou 3Department of Nephrology, Papanikolaou Hospital, Thessaloniki, Greece Stylianos Frangidis Stylianos Frangidis 3Department of Nephrology, Papanikolaou Hospital, Thessaloniki, Greece Apostolos Tsiandoulas Apostolos Tsiandoulas 2Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece Eleni Liakou Eleni Liakou 2Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece Gerasimos Bamichas Gerasimos Bamichas 3Department of Nephrology, Papanikolaou Hospital, Thessaloniki, Greece Maria Stangou Maria Stangou 4Hippokration Hospital Thessaloniki,Greece Aikaterini Papagianni Aikaterini Papagianni 4Hippokration Hospital Thessaloniki,Greece Georgios Efstratiadis Georgios Efstratiadis 2Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece Taisir Natse Taisir Natse 3Department of Nephrology, Papanikolaou Hospital, Thessaloniki, Greece Dimitrios Memmos Dimitrios Memmos 2Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece Abstract Introduction and Aims: More than two years passed since the publication of the K/DIGO guidelines for Chronic Kidney Disease -Mineral and Bone Disorder (CKD-MBD), who recommended more flexible ranges for iPTH, calcium and phosphorous. In the present study we evaluated the impact of the implementation of these guidelines on our clinical practice. Methods: We studied retrospectively n = 152 patients on chronic hemodialysis up to one year before the publication of K/DIGO and until the present day. Patients who had previously undergone parathyroidectomy or had constantly low iPTH levels ( < 2 x the normal value of our laboratory) were excluded from the study. A total of 4564 patients-months were analysed (1037 before and 3527 after the publication of K/DIGO). Patients were treated with paricalcitol and/or cinacalcet according to physician?s judgment. Results: An increase in the mean calcium values (from 8.76 ± 0.73 before to 8.99 ± 0.74 mg/dl after the publication of K/DIGO) was observed (p < 0.001). In contrast, there was no significant change in the mean phosphorous (5.10 ± 1.3 ? 5.07 ± 1.3 mg/dl, ns) or iPTH levels (332 ± 243 ? 322 ± 220 pg/ml, ns). However, a significant increase in the percentage of patient- months with iPTH levels within the recommended range (2-9 x the normal value) was observed (69.8% ? 73.4%, p = 0.034). Treatment changes (adjustments in dose and way of administration of paricalcitol and/or cinacalcet) decreased from 6.0 ± 4.8 to 3.0 ± 3.6 changes per patient-year (p < 0.001). Although there was no significant difference in the percentage of patient-months under paricalcitol treatment (38.1% ? 40.1%, p = 0.254), a reduction of the mean weakly paricalcitol dose was observed (in the whole cohort: 5.8 ± 6.1 ? 5.0 ± 5.5 mg, p > 0.001, among patient-months under treatment: 9.4 ± 5.1 ? 8.2 ± 4.9 mg, p > 0.001). Physicians prescribed lower doses of paricalcitol for any given level of iPTH (2.5 ± 1.7 mg paricalcitol per week for every 100 pg/ml iPTH compared to 2.8 ± 1.8 before the publication of K/DIGO, p > 0.001). Similarly, a significant decrease in the patient-months under cinacalcet treatment was observed (46.7% ? 40.6%, p > 0.001), although the daily dose in the treated patients did slightly increase (56.4 ± 35 ? 59.9 ± 45 mg, p = 0.077). Furthermore, the mean dose of calcium-based phosphate binders decreased by 32% (p = 0.003). Conclusions: In our experience the implementation of the K/DIGO guidelines resulted in better iPTH control. Interestingly, this was achieved with less treatment adjustments. SAP565 ACHIEVEMENT OF THE NKF/K-DOQI RECOMMENDED TARGET VALUES FOR BONE AND MINERAL METABOLISM IN INCIDENT HAEMODIALYSIS PATIENTS: RESULTS OF THE FARO-2 COHORT Mario Cozzolino Mario Cozzolino 1Dmco, University of Milan, Renal Division, San Paolo Hospital, Milan, Italy Piergiorgio Messa Piergiorgio Messa 2Croff, Milan, Italy Diego Brancaccio Diego Brancaccio 3University of Milan Giuseppe Cannella Giuseppe Cannella 4H S Martino, Genova Sandro Mazzaferro Sandro Mazzaferro 5University La Sapienza, Rome Abstract Introduction and Aims: Mineral Bone Disorders (MBD) is a prevalent disease in haemodialysis (HD) patients. There are a few studies on incident HD patients. FARO-2 is an Italian study on newly HD patients evaluate the achievement of the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF/K-DOQI) recommended target values for serum calcium (Ca), phosphate (P), and intact parathyroid hormone (iPTH) levels, at the same time. Methods: FARO-2 is a longitudinal perspective observational study performed in 26 Italian dialysis Units. It evaluates incident HD patients and follows them every 6 months for a maximum of 36 months. Data were collected using a questionnaire with clinical, biochemical and therapeutic parameters obtained for each patient. Results: Of the 568 patients (68% male, mean age 65.5 ± 15.2 years) that were included in the survey, 128 patients (22.5%) were observed up to 36 months. The proportions of patients achieving the recommended targets decreased from 13.3 % (at least two parameters on target), to 3.9% (at least three parameters on target), to 3.1% (at least four parameters on target). The survival rate at 36 months was higher in incident HD patients on target for at least three MBD parameters compared to patients off target (Figure 1). Interestingly, the 31% of patients on target for three MBD parameters at least once during the 36 months of follow-up show a better survival rate compared to those that never reached these targets (Figure 2) Conclusions: Incident HD patients followed-up for 36 months showed a difficult achievement of MBD K- DOQI recommended target values. Our findings indicate that incident HD patients with at least once achievement for three parameters of MBD targets have a lower mortality risk.6 View largeDownload slide View largeDownload slide SAP566 MINERAL AND BONE DISORDER AMONG PARTICIPANTS IN THE CHINA DIALYSIS OUTCOMES AND PRACTICE PATTERNS STUDY (DOPPS): SERUM BIOMARKERS X Yu X Yu 1The First Affiliated Hospital Sun Yat-Sen University, Guangzhou, China B Bieber B Bieber 2Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States M Guidinger M Guidinger 3University of Michigan, Ann Arbor, Michigan, United States B Bieber B Bieber 2Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States X Yang X Yang 1The First Affiliated Hospital Sun Yat-Sen University, Guangzhou, China F Tentori F Tentori 2Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States Rl Pisoni Rl Pisoni 2Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States J Qian J Qian 4Department of Medicine, Renji Hospital, Shanghai, China N Chen N Chen 5Shanghai Ruijin Hospital, Shanghai, China Y Yan Y Yan 4Department of Medicine, Renji Hospital, Shanghai, China M Wang M Wang 6Peking University First Hospital, Beijing, China L Zuo L Zuo 6Peking University First Hospital, Beijing, China H Wang H Wang 6Peking University First Hospital, Beijing, China M Wang M Wang 2Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States J Albert J Albert 2Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States S Ramirez S Ramirez 2Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States Abstract Introduction and Aims: In an effort to describe hemodialysis practices and patient outcomes in emerging countries, the DOPPS has recently conducted a pilot study in three major Chinese cities (Beijing, Guangzhou and Shanghai). Abnormalities in markers of mineral and bone disorder (MBD) have been recognized as potential risk factors for cardiovascular disease in the ESRD population and have been associated with poor clinical outcomes. We report here findings related to management of MBD in the Chinese DOPPS study cohort and compared them to other DOPPS countries. Methods: The DOPPS includes a 2-stage random sampling of dialysis facilities and dialysis patients in participating countries thus allowing the collection of nationally representative data. For the China DOPPS pilot study, dialysis facilities were randomly selected from a comprehensive roster of dialysis units from the participating cities. This abstract presents descriptive analyses of MBD markers (serum calcium, phosphorus and PTH) and therapeutic agents of China DOPPS participants as compared to other DOPPS countries (Japan, Canada, United States [US], seven European countries +; Australia and New Zealand [Eur/ANZ]). Results: A total of 1379 ESRD patients were randomly selected from 15 dialysis facilities each in Beijing, Guangzhou and Shanghai (total N=45 dialysis facilities), with 432, 439 and 508 patients from Beijing, Guangzhou and Shanghai, respectively. The mean serum calcium was slightly lower in the China DOPPS sample (9.0 mg/dl) compared to other DOPPS countries (Japan: 9.2, Canada: 9.2, US: 9.1 and Eur/ANZ: 9.2). Mean serum phosphorus was also higher in China (6.1 mg/dl, Japan: 5.5, Canada: 5.2, US: 5.3 and Eur/ANZ: 5.0). These differences may in part be explained by better nutritional status, as indicated by the fact that the % of DOPPS participants with normal ( > 4.0 g/dl) serum albumin was dramatically higher in China (43.3%) than in other countries (Japan: 19.1%, Canada: 18.5%, US: 28.1%, Eur/ANZ: 25.0%). Mean PTH was (399 pg/ml) in China and was lower than Canada but higher than other DOPPS countries. The distribution of DOPPS participants by MBD markers categories in each DOPPS country is shown below:6 Table 1. Percent of patients in each MBD marker category, by DOPPS region     *Albumin corrected Conclusions: Preliminary findings from the China DOPPS study indicate that MBD practices in China may differ significantly from those of other countries. The potential impact of these practices on patient outcomes will be examined in the longitudinal component of the China DOPPS study. SAP567 MINERAL METABOLISM IN HEMODIALYSIS PATIENTS BETWEEN GUIDELINES AND CLINICAL PRACTICE: A 3 YEARS RETROSPECTIVE OBSERVATIONAL STUDY Francesco Caccetta Francesco Caccetta 1"Card. G. Panico " Hospital, Tricase - Italy Maurizio Caroppo Maurizio Caroppo 2"Card. G. Panico" Hospital Fernando Musio Fernando Musio 2"Card. G. Panico" Hospital Anna Mudoni Anna Mudoni 2"Card. G. Panico" Hospital Antonella Accogli Antonella Accogli 2"Card. G. Panico" Hospital Maria Dolores Zacheo Maria Dolores Zacheo 2"Card. G. Panico" Hospital Vitale Nuzzo Vitale Nuzzo 2"Card. G. Panico" Hospital Abstract Introduction and Aims: The abnormalities of mineral metabolism are common in hemodialysis patients and have a significant impact in terms of morbidity and mortality. In order to assess the adherence to guidelines for the treatment of secondary hyperparathyroidism (SHPT) and the achievement of K/DOQI targets a 3 years retrospective observational study was conducted. Methods: 77 patients (38 M - 39 F), mean age 65.4 ± 13 years and duration of dialysis 90.1 ± 56.5 months, were enrolled in the study. For each patient the annual averages of corrected calcium (Ca), phosphorus (P), calcium-phosphorus product (CaxP), intact parathyroid hormone (PTHi) were calculated, and analyzed to evaluate the percentage of patients who met the K/DOQI targets by year and number of simultaneous target achieved (Ca, P, PTH). Were finally analyzed the changes in drugs requirement (vitamin D, phosphate binders and calcimimetics) for each period of 12 months. Results: Blood levels of Ca remained stable at 3 years (from 9.59 ± 0.51 mg/dl to 9.61 ± 0.53 mg/dl, p = ns), as well as those of P (from 4.88 ± 1.03 mg/dl to 4.76 ± 1.1 mg/dl, p = ns), CaxP (from 46.6 ± 6 to 45.7 ± 10.5 mg2/dl2 p = ns) and PTHi (from 325.6 ± 179.8 pg/ml to 307.4 ± 142.1 pg/ml, p = ns). Significantly changed the percentage of patients achieving the target value for the PTHi (from 40.2% to 57.1%, p < 0.03). At 3 years, 46.7% achieved the target value for Ca, 75.3% for P, and 81.1% for CaxP. After 36 months was significantly reduced the percentage of patients who did not reach any target (from 15.5% to 5.1%, p < 0.03). The 31.1%, the 36.3% and 27.2% respectively reached 1, 2 and 3 targets. The use of calcitriol has varied significantly (from 40.2% to 25.9%, p < 0.05) as well as that of paricalcitol (from 29.8% to 45.4%, p < 0.04) and calcimimetics (from 16.8% to 29.8%, p < 0.05). Equally varied is the prescription of calcium-based phosphate binders (from 30.1% to 17.3%, p < 0.04) and the percentage of patients who made use of two phosphate binders (from 22% to 10.5%, p < 0.04). Conclusions: The achievement of target values for the parameters of mineral metabolism remains, even in the long period of application of the K/DOQI guidelines, difficult and complex. Although they are not produced significant changes in blood levels of 3-year average of Ca, P and PTHi and only 27.7% is found to achieve the target for all 3 parameters, the use of new drugs (paricalcitol and calcimimetics) and the reduction of use of calcitriol and calcium-based phosphate binders seem to be able to optimize a higher percentage of patients reaching the target for PTHi, Ca and P and so allow a more positive modulation of the SHPT. SAP568 SERUM IPTH, CALCIUM AND PHOSPHATE, AND ALL-CAUSE AND CARDIOVASCULAR MORTALITY IN HEMODYALISIS PATIENTS: A SINGLE - CENTER 5 YEAR FOLLOW-UP ANALYSIS Gjulsen Selim Gjulsen Selim 1University Clinic of Nephrology, University “sts. Cyril and Methodius” Skopje, R. Macedonia Gjulsen Selim Gjulsen Selim 2University Clinic of Nephrology Olivera Stojceva-Taneva Olivera Stojceva-Taneva 1University Clinic of Nephrology, University “sts. Cyril and Methodius” Skopje, R. Macedonia Liljana Tozija Liljana Tozija 1University Clinic of Nephrology, University “sts. Cyril and Methodius” Skopje, R. Macedonia Saso Gelev Saso Gelev 1University Clinic of Nephrology, University “sts. Cyril and Methodius” Skopje, R. Macedonia Vlatko Pusevski Vlatko Pusevski 1University Clinic of Nephrology, University “sts. Cyril and Methodius” Skopje, R. Macedonia Pavlina Dzekova-Vidimliski Pavlina Dzekova-Vidimliski 1University Clinic of Nephrology, University “sts. Cyril and Methodius” Skopje, R. Macedonia Irena Rambabova-Busletic Irena Rambabova-Busletic 1University Clinic of Nephrology, University “sts. Cyril and Methodius” Skopje, R. Macedonia Aleksandar Sikole Aleksandar Sikole 1University Clinic of Nephrology, University “sts. Cyril and Methodius” Skopje, R. Macedonia Abstract Introduction and Aims: Mineral and bone disorders frequently cause all-cause and cardiovascular complications and mortality in hemodialysis (HD) patients. The association between the markers of mineral and bone disease and clinical outcomes was examined in 261 prevalent HD patients treated in our Department. Methods: A total of 261 prevalent HD patients (mean age at beginning of HD 49.69 ± 15.59 years, mean HD vintage 99.54 ± 72.15 months, diabetes 17.2%) were prospectively followed up for 60 months and all-cause and CV mortality were registered. Blood samples were collected pre- dialysis at the start of the study and within the regular 1-month intervals for calcium and phosphate and 4-months interval for intact parathyroid hormone (iPTH), a period of 60 months. Individual measures for iPTH, calcium and phosphate were divided into clinically relevant categories: iPTH ( < 150; 150–300; 300–600; > 600pg/mL), calcium ( < 2.1; 2.1–2.37; > 2.37mmol/l) and phosphate ( < 1.10; 1.10–1.78; > 1.78mmol/l). Cox models were performed to assess the relationship of serum iPTH, calcium and phosphate level with all-cause and cardiovascular disease (CVD) mortality. Results: During the 5-year follow-up, 117 out of 261 patients (44.8%) had died, most from CVD (63.2%). Mean serum calcium level was 2.28 ± 0.15 mmol/L (1.18 – 2.71), phosphate 1.50 ± 0.35mmol/l (0.63 -2.78) and iPTH 206.02 ± 223.03 pg/ml (2.3 – 1671). 62% of the patients achieved calcium levels between 2.1–2.37mmol/l, 69% of patients achieved phosphate levels between 1.10 -1.78 mmol/l and only 25% of patients achieved iPTH between 150-300pg/mL. The majority of patients, 53.3% had iPTH < 150pg/mL. Serum phosphate ( < 1.1 vs 1.1–1.78 and > 1.78 vs 1.1–1.78 mmol/l) and calcium levels ( < 2.1 vs 2.1–2.4 and > 2.4 vs 2.37 mmol/l) were not related to all-cause and cardiovascular mortality. Patients in the lowest iPTH category ( < 150 pg/mL) had increase risk [HR 1.94; 95% confidence interval (CI) 1.19–4.86, p = 0.014] for all-cause and cardiovascular mortality [HR 3.5; 95% confidence interval (CI) 1.25–9.81, p = 0.017] compared to patients with iPTH between 300-600 pg/mL. Conclusions: Our results suggest that between the markers of mineral and bone disease, patients in the lowest iPTH category ( < 150 pg/mL) have the highest risk of all-cause and cardiovascular mortality. SAP569 OBSTACLES TO MINERAL METABOLISM CONTROL IN HEMODIALYSIS PATIENTS: FIRST RESULTS FROM THE ITALIAN NATIONAL AUDIT. Pasquale Esposito Pasquale Esposito 1Nephrology, Dialysis, Transplantation; Fondazione Irccs Policlinico San Matteo; Pavia, Italy Pasquale Esposito Pasquale Esposito 2Policlinico "San Matteo", Pavia Rosanna Coppo Rosanna Coppo 3Nephrology, Dialysis, Transplantation, Regina Margherita University Hospital, Turin, Italy Fabio Malberti Fabio Malberti 4Department of Nephrology. Istituti Ospitalieri, Cremona- Italy Antonio Dal Canton Antonio Dal Canton 1Nephrology, Dialysis, Transplantation; Fondazione Irccs Policlinico San Matteo; Pavia, Italy Abstract Introduction and Aims: In patients on haemodialysis (HD), mineral metabolism disorders are related to high morbidity and mortality. In spite of several diagnostic and therapeutic tools, attempts to control mineral metabolism are often unsuccessful. We designed a clinical audit to identify the obstacles, which make difficult to achieve the therapeutic targets. Methods: 510 adult prevalent patients undergoing HD in 36 italian dialysis centers were audited. On an individual chart we collected data about the center policy, laboratory methodology and examinations, clinical characteristics, nutritional state, drug therapy and compliance. After the collection, data was analysed to suggest strategies to improve mineral metabolism control. Results: 19 centers (53%) adopted the 2009 KDIGO guidelines, while 17 adopted the 2003 KDOQI guidelines. 11 kits were used to measure PTH with 3 different laboratory methods (IRMA, RIA, ELISA). Patients' age was 66.1 ± 14.3 years, with a median dialytic age of 67.1 ± 51.3 months. spKV/T was 1.37 ± 0.28, nPCR 1.3 ± 0.6 g/kg/day and dialysate calcium content 1.5 mmol/L in the 80.5% of pts. 64 patients (12.5%) presented a history of fractures, while 268 (52%) documented vascular calcifications. Mean PTH levels were 313.7 ± 296.2 pg/ml. The 39.8% and 67.5% of treated patients achieved the therapeutic target in centers adopting the KDOQI and KDIGO guidelines, respectively. Mean phosphorus and calcium levels were 4.8 ± 1.5 mg/dl and 8.7 ± 1.5 mg/dl, respectively. 25-OH vitamin D was dosed only in 13 centers (36%) and its mean concentration was low in the vast majority of cases (17.9 ± 13.1 ng/ml, normal values > 32 ng/ml). 127 patients (25%) had a specifically prescribed diet. 375 patients received a phosphate binder, including 50 patients treated with aluminium. Calcium was assumed by 204 (40%) patients, in the form of both binder and nutritional supplement. 330 patients received vitamin D (179 calcitriol, 152 paracalcitol), while only 8 patients received 25-OH vitamin D supplements. The 34% of patients presented a low compliance, according to physicians' opinion. Conclusions: The audit highlighted some interesting issues. First of all, there is a diffused heterogeneity of guidelines and laboratory methods used in different centers. Moreover, only few patients receive a dietician counselling, and there is a little consideration for 25-OH vitamin D, while it is still prevalent and excessive the use of calcium and aluminium. Finally, the compliance to therapy remains a challenge. All these factors may potentially affect the mineral metabolism control and could, at least in part, account for the low rate of patients reaching therapeutic targets. Strategies, such as the standardization of guidelines and laboratory techniques, and the establishment of an individual integral approach to the patient, including a critical revision of drug treatment as well as dietician and psychologist counselling, could be useful to face these issues. The effectiveness of these strategies will be evaluated in the perspective phase of the audit. SAP570 COST-EFFECTIVENESS OF 99MTC-MIBI SCINTIGRAPHY FOR HAEMODIALYSIS PATIENTS WITH PERSISTENT OR RECURRENT HYPERPARATHYROIDISM IN JAPAN Kensuke Moriwaki Kensuke Moriwaki 1Department of Health Informatics, Niigata University of Health and Welfare, Niigata, Japan Hirotaka Komaba Hirotaka Komaba 2Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan Takatoshi Kakuta Takatoshi Kakuta 2Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan Masafumi Fukagawa Masafumi Fukagawa 2Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan Abstract Introduction and Aims: Parathyroidectomy dramatically improves secondary hyperparathyroidism (SHPT), but the presence of ectopic parathyroid glands can lead to persistent or recurrent SHPT. 99mTc-MIBI scintigraphy is a sensitive procedure to identify such ectopic glands and is commonly employed for patients with persistent or recurrent SHPT. The objective of this study was to assess the economic value of 99mTc-MIBI scintigraphy in haemodialysis patients with persistent or recurrent SHPT in Japan. Methods: A Markov model was constructed to project clinical outcomes, health care costs, and cost- effectiveness of 99mTc-MIBI scintigraphy as addition to computed tomography (CT) compared with CT alone for haemodialysis patients with persistent or recurrent SHPT in Japan. Sensitivities of 99mTc-MIBI scintigraphy and CT for detection of parathyroid hyperplasia were derived from published literature. Thoracoscopic parathyroidectomy was performed for patients in whom ectopic parathyroid glands were identified by these imaging procedures. Patients were followed up over their lifetime. Costing was undertaken from the perspective of the third party health care payer in Japan. Dialysis costs were not included in the base case. Uncertainty was explored through sensitivity analyses. Results: In a hypothetical cohort of 1,000 patients with persistent or recurrent SHPT, thoracoscopic parathyroidectomy was performed in 72.0% of patients undergoing 99mTc-MIBI scintigraphy plus CT and in 40.0% of patients undergoing CT alone. Compared with CT alone, 99mTc- MIBI scintigraphy cost an additional US$2,932 per person and conferred an additional 0.399 quality adjusted life years (QALYs), resulting in an incremental cost-effectiveness ratio of US$7,348 per QALY gained. Sensitivity analyses showed that the results were robust to variations in the model parameters. In the probabilistic sensitivity analysis, 99mTc-MIBI scintigraphy was cost-effective in more than 99.9% of simulations, if society would be willing to pay $50,000 per additional QALY. Conclusions: 99mTc-MIBI scintigraphy is likely to be cost-effective for preoperative identification of ectopic parathyroid glands in haemodialysis patients with persistent or recurrent SHPT in Japan. SAP571 POTENTIAL ROLE OF RELAXIN IN RENAL OSTEODYSTROPHY Valeria Cernaro Valeria Cernaro 1Polyclinic of Messina, Department of Internal Medicine, Division of Nephrology Rosaria Lupica Rosaria Lupica 1Polyclinic of Messina, Department of Internal Medicine, Division of Nephrology Valentina Donato Valentina Donato 1Polyclinic of Messina, Department of Internal Medicine, Division of Nephrology Antonio Lacquaniti Antonio Lacquaniti 1Polyclinic of Messina, Department of Internal Medicine, Division of Nephrology Maria Rosaria Fazio Maria Rosaria Fazio 1Polyclinic of Messina, Department of Internal Medicine, Division of Nephrology Silvia Lucisano Silvia Lucisano 1Polyclinic of Messina, Department of Internal Medicine, Division of Nephrology Michele Buemi Michele Buemi 1Polyclinic of Messina, Department of Internal Medicine, Division of Nephrology Abstract Introduction and Aims: According to literature, the 6 kDa-peptidic-hormone relaxin is best known for the physiological role played in the renal and systemic haemodynamic changes occurring during pregnancy. Many data show that it can also be involved in the pathophysiology of arterial hypertension and heart failure, in the molecular pathways underlying fibrosis and cancer, in angiogenesis and bone remodeling. Such pleiotropic effects are mediated by its binding to different receptors, called relaxin family peptide (RXFP) receptors (RXFP1-4). Our aim has been to evaluate relaxin's serum levels in a group of hemodialyzed (HD) patients at baseline and the correlations with biochemical parameters related to bone metabolism. Methods: We enrolled a group of patients affected by chronic renal failure (CRF) as control (n = 21 III stage, n = 15 IV stage, n = 21 V stage) and a cohort of 24 patients (13 women, 11 men; mean age, 62.1 ± 13 years; dialysis vintage in months, 34 [10-284]; residual GFR 2.6 ± 0.5 ml/min) receiving dialytic treatment in 3-hour sessions, 3 times a week, employing the AFB technique. Relaxin's levels were assessed using the commercial available Human Relaxin-2 Immunoassay kit (Quantikine®, R&D Systems, Inc.). Biochemical parameters were measured by the standard methods of the routine clinical laboratory. Results: Relaxin's values are higher in HD patients compared to all CRF patients (28.72 ± 6.92 vs 20.18 ± 6.90 pg/ml, p = 0.0001) (Fig. 1). In particular, the difference between CRF III and IV stage was no significant (21.17 ± 8.89 vs 17.94 ± 5.76 pg/ml, p = 0.22), as well as between CRF III and V stage (21.17 ± 8.89 vs 22.28 ± 2.79 pg/ml, p = 0.58), while it was statistically significant between CRF IV and V stage (17.94 ± 5.76 vs 22.28 ± 2.79 pg/ml, p = 0.005) and between CRF V stage and HD group (22.28 ± 2.79 vs 28.72 ± 6.92 pg/ml, p < 0.0001). Then, we evaluated the correlations between relaxin and other biochemical parameters, finding statistically significant correlations with parathyroid hormone (PTH) (p = 0.0139) and osteoprotegerin (OPG) (p = 0.03) in HD patients (Fig. 2). In patients with CRF there was no significant correlation between relaxin and these parameters. Conclusions: Relaxin regulates osteoclasts' activity and plays a role in bone physiology, diseases and metastasis, as already demonstrated. No data exist on its potential involvement in renal osteodystrophy. Our results allow to hypothesize that relaxin could represent a biomarker of the bone remodeling characterizing this clinical condition. Its influence on bone metabolism may be consequent to its modulating action on the RANKL (receptor activator of NF-?B ligand)/OPG system through RXFP1 receptor, as recently shown in a rat adjuvant-induced arthritis model. The higher relaxin's values we observed in HD patients may be an attempt to compensate hyperparathyroidism and bone tissue damage, by inducing an increase in circulating OPG and then a decrease in RANKL levels. The result would be a suppression of osteoclasts' formation and survival and a lower bone reabsorption. In conclusion, this hypothesis needs to be deepened, but our data suggest that the assessment of relaxin's levels could provide important diagnostic and prognostic information and guide our therapeutic choices for the best treatment of the patient.23 Figure 1 View largeDownload slide Relaxin's values are higher in HD patients compared to all CRF patients (28.72 ± 6.92 vs 20.18 ± 6.90 pg/ml). Figure 1 View largeDownload slide Relaxin's values are higher in HD patients compared to all CRF patients (28.72 ± 6.92 vs 20.18 ± 6.90 pg/ml). Figure 2 View largeDownload slide Correlations between relaxin and PTH and between relaxin and OPG at baseline. Figure 2 View largeDownload slide Correlations between relaxin and PTH and between relaxin and OPG at baseline. SAP572 SIGNIFICANT POSITIVE RELATIONSHIP BETWEEN SERUN UNDERCARBOXYLATED OSTEOCALCIN AND GLYCEMIC CONTROL IN MAINTENANCE HEMODIALYSIS PATIENTS Senji Okuno Senji Okuno 1Shigasagi Hospital, Osaka, Japan Eiji Ishimura Eiji Ishimura 2Osaka City University Graduate School of Medicine, Osaka, Japan Naoki Tsuboniwa Naoki Tsuboniwa 3Shirasagi Hospital, Osaka, Japan Kyoko Norimine Kyoko Norimine 3Shirasagi Hospital, Osaka, Japan Kenjiro Yamakawa Kenjiro Yamakawa 3Shirasagi Hospital, Osaka, Japan Tomoyuki Yamakawa Tomoyuki Yamakawa 3Shirasagi Hospital, Osaka, Japan Shigeichi Shoji Shigeichi Shoji 3Shirasagi Hospital, Osaka, Japan Katsuhito Mori Katsuhito Mori 4Osaka City University Graduate School of Medicine, Osaka, Japan Yoshiki Nishizawa Yoshiki Nishizawa 4Osaka City University Graduate School of Medicine, Osaka, Japan Masaaki Inaba Masaaki Inaba 4Osaka City University Graduate School of Medicine, Osaka, Japan Abstract Introduction and Aims: Osteocalcin (OC), which is the most abundant non-collagenous protein of bone matrix, is a marker of bone metabolism. Undercarboxylated OC (ucOC) is also reported to be associated with a reduced bone mass and a high risk of fracture. Recently, OC, in particular ucOC, has been shown to have a positive effect on both insulin production and insulin sensitivity. Several human studies have demonstrated that there are inverse associations between circulating OC and fasting plasma glucose, insulin resistance, hemoglobin A1C in patients with type 2 diabetes, and in population-based cohorts. However, these studies have not examined those with chronic kidney disease (CKD), in whom severe abnormalities of bone metabolism are present. We tested the hypothesis that ucOC levels are associated with indices of glucose metabolism independent of bone metabolic markers in chronic hemodialysis patients with abnormalities of bone metabolism. Methods: A total of 189 patients (96 diabetics and 93 non-diabetics) on maintenance hemodialysis were examined. The mean ( SD) age and hemodialysis duration of the patients were 68.5 11.1 years and 7.0 6.2 years, respectively. Blood sample was collected just before starting the hemodialysis session in a non-fasting state for the measurement of serum ucOC, intact parathyroid hormone (PTH), bone alkaline phosphatase (BAP, a bone formation marker), and tartrate-resistant acid phosphatase-5b (TRACP-5b, a bone resorption marker). Hemoglobin A1C, serum glycated albumin, and plasma glucose were measured as markers of glucose metabolism and their relationship with markers of bone metabolism was examined. Results: The median values (range) of the serum ucOC, BAP and TRACP-5b in all patients were 20.0 (2.2 - 257.4) ng/mL, 18.8 (8.2–69.2) U/L, and 311 (78 -1340) mU/dL, respectively. UcOC correlated significantly and positively with BAP, TRACP-5b, and intact PTH (r=0.489, p < 0.0001, r = 0.585, p < 0.0001, and r=0.621, p < 0.0001, respectively). Serum ucOC of diabetic patients was significantly lower than that of non-diabetic patients (p < 0.001), although there were no significant differences in serum BAP or TRACP-5b between diabetic and non- diabetic patients. Serum ucOC correlated significantly and negatively with plasma glucose (r=-0.303, p < 0.0001), hemoglobin A1C (r=-0.214, p < 0.01), and glycated albumin (r=-0.271, p < 0.001), although serum BAP or TRACP-5b did not. In multiple linear regression analysis, serum log [ucOC] was significantly associated with presence of diabetes, log [plasma glucose], log [hemoglobin A1C], and log [glycated albumin], respectively, after adjustment with age, gender, hemodialysis duration, body mass index, log [BAP], log [TRACP-5b], and log [intact PTH]. Conclusions: Increased levels of serum ucOC, which were significantly associated with bone metabolism markers, were inversely associated with glucose metabolism in hemodialysis patients, independently to bone metabolism markers. These findings suggest that ucOC has a distinct association with glucose metabolism, in addition to being an index of bone markers in hemodialysis patients. SAP573 IS VITAMIN D A CONCERN IN BLACK AFRICAN HEMODIALYSIS PATIENTS? Mohamed Dahaba Mohamed Dahaba 1Polyclinic Abc, Dakar, Senegal Sidy Seck Sidy Seck 2University Gaston Berger, Saint-Louis, Senegal Moustapha Cisse Moustapha Cisse 1Polyclinic Abc, Dakar, Senegal Abstract Introduction and Aims: Vitamin D deficiency is a widespread condition in many countries and dialysis patients are more exposed than general population. Furthermore, black individuals have a higher risk due to skin pigmentation with is a barrier to UVs. However, studies on vitamin D deficiency in dialysis patients are very rare in sub-Saharan Africa and data from black people living in the United States might not applicable for African patients whose dietary habits and sunlight exposure are different. This study assessed prevalence of the deficit in 25 (OH) vitamin D in hemodialysis patients in Senegal. Methods: We performed a cross-sectional study including 43 hemodialysis patients from two Senegalese centers. We collected for each patient clinical and biological data. Serum 25(OH) vitamin D level was dosed by electrochemiluminescence process. Deficiency was defined as a serum 25 (OH) vitamin D level < 75 nmol/l and a level < 37.5 nmol/l was considered as vitamin D carency. A serum vitamin D concentration between 75 and 250 nmol/l was considered as normal. Statistical analysis was done using SPSS 16.0. Results: Mean age of patients was 38 ± 12 years with 46.5% of females. Prevalence of vitamin D deficiency was 53.13%, with 15% presenting carency. The mean dialysis vintage was 36 ± 29 months. All patients had been dialysed with a 1.75 mmol/l calcium and bicarbonate rich dialysate. Treatment with alfacalcidol was given in 66% of patients. Patients with vitamin D deficiency had a longer dialysis vintage (41 versus 23 months, p = 0.02), a higher proportion of females (40% versus 15%, p = 0.02), and a higher level of PTH (276 versus 201 pg/mL, p = 0.05) than those with normal. We found no relationship between vitamin D levels and age, BMI, bone markers, phosphorus, albumin, normalized protein catabolic rate and PTH level. After multivariate analysis, only calcemia appeared significantly associated with vitamin D deficiency (OR = 0.54, p = 0.04). Conclusions: Vitamin D deficiency might be underestimated among dialysis patients living Africa. Calcemia is the main associated factor. Further intervention studies are needed to explore the potential renal, bone and cardiovascular benefits benefits of 25(OH) vitamin D supplementation in this population. SAP574 THE CONTROL OF CORRECTED CALCIUM, PHOSPHORUS AND INTACT-PTH WITHOUT SEVELAMER HCL FOLLOWING THE 2011 DISASTER IN JAPAN Yukinori Jotoku Yukinori Jotoku 1Matuyama, Ehime Yuzuyu Sato Yuzuyu Sato 2Matsuyama, Ehime Abstract Introduction and Aims: A huge earthquake and tsunami hit the east coast of Japan at March 11, 2011 and many lives were lost and factories destroyed. One of such factory was the only one in Japan that manufactured sevelamer HCl . As a result, we were unable to use sevelamer HCl as a phosphate binder after supplies ran out two months later. Methods: Seventy-one patients on HD receiving sevelamer HCl were divided into 5 groups according to the alternative methods. Group 1 received newly administered or increased dosages of calcium carbonate (N=16, from 2.0 ± 2.4 to 4.1 ± 3.0g/day). Group 2 received newly administered or increased dosages of lanthanum carbonate (N=23, from 0.6 ± 0.6 to 1.6 ± 1.0g/day). Group 3 received a decreased dosage of vitamin D (N=14). Group 4 received newly administered or increased dosages of cinacalcet HCl (N=3, from 6.3 to 31.3mg/day) and group 5 received other treatments such as a restriction on phosphorus intake (N=21). We compared the laboratory findings, including plasma concentration of corrected Ca, phosphorus, intact-PTH, total cholesterol, triglyceride, HDL-cholesterol and LDL-cholesterol at the time of the change with the lab results from five months later. Results: All of the laboratory findings from before and after the changes showed no significant differences in any of the groups. None of the alternative methods influenced lipid metabolism. Conclusions: This was the first experience of this kind worldwide following a huge disaster. All of the alternative methods were found to be useful for the control of corrected calcium, phosphorus and intact-PTH. These findings should prove beneficial in helping to prepare for similar events in the future.7 Table 1.     SAP575 A MULTI-CENTRE, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, MULTIPLE FIXED-DOSE STUDY OF COLESTILAN (MCI-196) VERSUS PLACEBO IN CHRONIC KIDNEY DISEASE STAGE 5 SUBJECTS ON DIALYSIS (CKD 5D) WITH HYPERPHOSPHATAEMIA AND DYSLIPIDAEMIA (DL): SAFETY RESULTS Nada Dimkovic Nada Dimkovic 1Clinical Department of Renal Diseases, Zvezdara University Medical Center, Belgrade Abstract Introduction and Aims: Calcium-based phosphate binders have significant limitations due to the potential for long- term increased serum calcium levels with the associated risk of increased cardiovascular morbidity and mortality. This study was one of several phase III therapeutic confirmatory studies designed to demonstrate the efficacy and safety of different doses of a novel non- calcium, non-absorbed anion exchange resin colestilan (COL) for the treatment of hyperphosphataemia. Methods: This multi-centre study consisted of a washout period, followed by randomisation to treatment at the baseline visit and a 12-week fixed-dose, double-blind, placebo-controlled treatment period, and a safety follow-up visit. This parallel-group study included 5 active COL treatment groups: 3 g, 6 g, 9 g, 12 g and 15 g per day. Subjects receiving COL 3 g and 6 g per day also received 6 and 3 matching placebo tablets per day, respectively, so that all subjects in the 3 g, 6 g and 9 g per day groups took 9 tablets per day in total. There were matching placebo groups in which subjects received placebo 9, 12 o r 15 tablets per day. 639 patients were analysed for safety by means of descriptive statistics (frequency of adverse events, changes in vital signs, safety laboratory parameters, physical examination, prior and concomitant medications, and ECG) Results: Overall, 324/639 subjects (50.7%) experienced at least 1 treatment emergent adverse event (TEAE). The TEAEs were most frequently reported in the gastrointestinal disorders System Organ Class, overall 177/639 subjects (27.7%), and in each treatment group, with the most frequently reported TEAEs (=5% of subjects) being nausea, vomiting, dyspepsia and diarrhoea. For nausea and vomiting, the incidence was higher in the MCI-196 groups compared to placebo, and showed a dose relationship. Treatment-related TEAEs were reported by 164/639 subjects (25.7%) with 18.2% in placebo group and 16.3%, 24.5%, 28.6%, 32.4% and 36.6% for 3g, 6g, 9g, 12g and 15g COL groups, respectively. Fifty-nine subjects (9.2%) experienced TEAEs with the action taken regarding study medication reported as ‘discontinued’, of which the most frequent, overall and by treatment group, was nausea. Few laboratory abnormalities were reported as TEAEs, all non-serious. No notable differences were observed between treatment groups or over time in vital signs, 12-lead ECG and physical examination parameters. Six subjects (0.9%) died during the study, but no deaths were considered related to study medication. COL produced a clinically relevant reduction in serum phosphorus and LDL-C. When compared to placebo, at Week 12 COL significantly reduced serum phosphorus from Baseline, in a dose-dependent manner, at doses 9 g and higher (mean change from Baseline at 9 g, 12 g and 15 g of -0.314 mmol/L, -0.228 mmol/L and -0.456 mmol/L, respectively). COL had also beneficial effect on serum CaxP product, uric acid and HbA1c without altering serum calcium, iPTH and CRP levels Conclusions: COL was demonstrated to be safe and well tolerated, with TEAEs and discontinuations due to TEAEs being primarily related to the GI system, as is expected from the physicochemical profile of the medication. In meeting the co-primary endpoints of serum phosphorus and serum LDL-C, as well as a favourable safety profile, the findings of this study support the conclusion that COL is both safe and effective as a treatment for hyperphosphataemia and dyslipidaemia in subjects with CKD stage V on dialysis. SAP576 FGF-23 LEVELS ARE ASSOCIATED WITH VASCULAR CALCIFICATION IN PERITONEAL DIALYSIS PATIENTS Ebru Asicioglu Ebru Asicioglu 1Marmara Universitesi Pendik Egitim Ve Arastirma Hastanesi, Istanbul, Turkey Arzu Kahveci Arzu Kahveci 2Marmara Universitesi Pendik Egitim Ve Arastirma Hastanesi Hakki Arikan Hakki Arikan 2Marmara Universitesi Pendik Egitim Ve Arastirma Hastanesi Mehmet Koc Mehmet Koc 3Marmara University Medical Faculty, Division of Nephrolgy Serhan Tuglular Serhan Tuglular 2Marmara Universitesi Pendik Egitim Ve Arastirma Hastanesi Cetin Ozener Cetin Ozener 2Marmara Universitesi Pendik Egitim Ve Arastirma Hastanesi Abstract Introduction and Aims: End-stage renal disease patients with vascular calcifications (VC) have the highest cardiovascular morbidity and mortality. FGF-23 plays a major role in phosphorus regulation, which is associated with the development of VC. The aim of this study is to investigate the relationship between FGF-23 levels and VC. Methods: Fifty peritoneal dialysis (PD) patients and 40 healthy controls were included in the study. FGF-23 levels were determined from plasma samples. Plain radiographic pelvic films for VC were obtained for all patients. Patients with and without VC were classified as Group 1 and 2, respectively. Results: FGF-23 levels were significantly increased in PD patients as compared to controls (334.8 ± 78.6 vs 8.8 ± 0.9 pg/mL, p < 0.01). There were 15 patients in Group 1 (27 %) and 40 patients in Group 2 (73 %). Age, gender, waist circumference, BMI, dialysis modality, transport type, Kt/V, blood pressure, lipid profile, albumin, P, PTH, 25-OH-D and CRP levels were similar in both groups (Table 1). FGF-23 levels were significantly higher in Group 1 as compared to Group 2 (724.7 ± 871.1 vs 178.9 ± 222.3 pg/mL, p < 0.01). Patients in Group 1 had longer dialysis duration (80.5 ± 46.4 vs 30.1 ± 36.9 months, p < 0.01), less residual renal function (RRF) (78.3 ± 207.2 vs 694,9 ± 702,3 mL/day, p < 0.01), higher Ca (9.6 ± 0.8 vs 8.8 ± 0.8 mg/dL, p < 0.01) and HbA1c levels (6.1 ± 1.0 vs 5.6 ± 1.2, p < 0.05) as well as lower ALP (213.8 ± 86.7 vs 390.6 ± 382.7 U/L, p < 0.05). Diabetics had more VCs (56 % vs 22 %, p < 0.05). FGF-23 levels, Ca, dialysis duration, diabetes and HbA1c were positively correlated with VC, whereas RRF and ALP were negatively associated. Logistic regression analysis confirmed that FGF-23 levels, dialysis duration, diabetes and RRF were independent predictors for VC. Conclusions: FGF-23 levels are associated with vascular calcification in PD patients.8 Table 1. Demographic and laboratory data for Group 1 and Group 2     SAP577 CONSISTENT MANAGEMENT OF MINERAL-AND-BONE DISORDER: A CASE-COHORT STUDY OF CAUSES OF DEATH IN HEMODIALYSIS PATIENTS WITH SECONDARY HYPERPARATHYROIDISM Masafumi Fukagawa Masafumi Fukagawa 1Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine Masafumi Fukagawa Masafumi Fukagawa 2Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan Ryo Kido Ryo Kido 3Institute for Health Outcomes and Process Evaluation Research (Ihope International) Hirotaka Komaba Hirotaka Komaba 1Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine Yoshihiro Onishi Yoshihiro Onishi 3Institute for Health Outcomes and Process Evaluation Research (Ihope International) Takuhiro Yamaguch Takuhiro Yamaguch 4Division of Biostatistics Tohoku University Graduate School of Medicine Takeshi Hasegawa Takeshi Hasegawa 5Division of Nephrology, Department of Internal Medicine, Showa University Fujigaoka Hospital Noriaki Kurita Noriaki Kurita 6Department of Epidemiology and Healthcare Research, Graduate School of Medicine and Public Health, Kyoto University Tadao Akizawa Tadao Akizawa 7Division of Nephrology, Department of Medicine, Showa University School of Medicine Kiyoshi Kurokawa Kiyoshi Kurokawa 8National Graduate Institute for Policy Studies Shunichi Fukuhara Shunichi Fukuhara 9Department of Epidemiology and Healthcare Research, School of Public Health, University of Kyoto Abstract Introduction and Aims: In patients with renal disease, mortality is related to mineral and bone disorder (MBD). Most previous studies of MBD outcomes have included dialysis patients who do not have secondary hyperparathyroidism (SHPT), and many such studies have also included patients who were not being treated for MBD. In addition, MBD control has usually been assessed on the basis of laboratory results measured at baseline. Some studies have included time- dependent analyses of MBD control, but none have used methods that allow cause-effect inferences. In this study, we included only dialysis patients who had SHPT. By using marginal structural models, we could make inferences about the effects of consistent control of MBD on clinical outcomes. Methods: The Mineral and Bone Disorder Outcomes Study for Japanese CKD Stage 5D Patients (MBD- 5D) was a 3-year prospective case-cohort study which analyzed 8229 hemodialysis patients with SHPT in 86 facilities in Japan. All patients had either an iPTH of at least 180 pg/ml or were receiving intravenous active vitamin D sterols or the oral active vitamin D analogue falecalcitriol. Data were prospectively collected every 3 months between 2008 and 2011 from subjects in a sub-cohort consisting of a randomly selected 40% of the whole cohort, and retrospectively from those who had died. We examined the association of the consistency in levels of MBD markers (Ca, by 0.5; P, by 1.0; iPTH, by 100) or the achievement of the Japanese guideline-specified targets (Ca, 8.4 to 10.0, mg/dl; P, 3.5 to 6.0, mg/dl; iPTH, 60 to 180, pg/dl) with mortality. A marginal structural Cox proportional hazards model was used to evaluate the effects of consistency of MBD marker levels, with adjustment for time-varying MBD treatments (phosphate binders, vitamin D receptor activators, and cinacalcet) as time- dependent confounders which may be affected by previous levels of MBD markers, and which may modify their future levels. Results: Subjects (mean age 62 years; 62% male) had a median duration of hemodialysis of 8.3 years (interquartile range; 3.7 to 14.3). A total of 1226 deaths (14.9%) were recorded during the study period. On analysis with respective MBD markers categorized into detailed subgroups, higher Ca ( > 10), lower P ( < 4), and lower iPTH ( < 100) levels were associated with increased mortality. Hyperphosphatemia ( > 8) showed a trend toward increased mortality. Deviation from the respective ranges of MBD markers designated by the practice guideline, namely higher Ca ( > 10; Hazard ratio, HR, 1.69, 95%CI 1.45 to 1.96), lower P ( < 3.5; HR 1.99, 95%CI 1.58 to 2.51), and lower iPTH levels ( < 60; HR 1.34, 95%CI 1.04 to 1.74) heightened mortality risk. Conclusions: Our results clarified the range of MBD marker levels which heighten mortality risk. Consistent achievement of the national guideline-specified targets may likely improve the survival of hemodialysis patients with SHPT in real-world settings. SAP578 BOTH VASCULAR AND VALVULAR CALCIFICATION ARE STRONG PREDICTORS OF 6-YEARS MORTALITY IN NON-DIABETIC PATIENTS ON MAINTENANCE HEMODIALYSIS. Andrzej Krasniak Andrzej Krasniak 1Chair and Department of Nephrology, Jagiellonian University, Krakow, Poland Maciej Drozdz Maciej Drozdz 1Chair and Department of Nephrology, Jagiellonian University, Krakow, Poland Grzegorz Chmiel Grzegorz Chmiel 1Chair and Department of Nephrology, Jagiellonian University, Krakow, Poland Piotr Podolec Piotr Podolec 2Institute of Cardiology, Krakow, Poland Mieczyslaw Pasowicz Mieczyslaw Pasowicz 3Intitute of Cardiology, Krakow, Poland Martyna Kowalczyk-Michalek Martyna Kowalczyk-Michalek 1Chair and Department of Nephrology, Jagiellonian University, Krakow, Poland Wladyslaw Sulowicz Wladyslaw Sulowicz 1Chair and Department of Nephrology, Jagiellonian University, Krakow, Poland Abstract Introduction and Aims: Very high cardiovascular mortality and morbidity in HD patients may be strongly associated with valvular and vascular calcification. The aim of the study was to find the predictors of mortality in HD patients during 6-yrs. observation period. Methods: The aim of the study was to find the predictors of mortality in HD patients during 6-yrs. observation period. The study group was composed of 65 patients (30 M, 35 F) aged 25-75 years (mean 49.6) hemodialyzed three times a week for 12-275 mo. (mean 73.9 mo.), observed during 6 years period. All patients underwent echocardiographic assessment with heart valves evaluation, Calcium Score (CACS) calculation using CT and B-mode ultrasound of carotid arteries with IMT assessment at the start observation. The self-elaborated Cumulative Calcification Index was calculated as a sum of the number of calcified heart valves; CACS Index according to Rumberger et al. (CS < 10–0, 10 < CS < 100–1, 100 < CS < 400–2, CS > 400–3 points) and number of calcified plaques in carotid arteries (0–0, 1–1, 2–2, 3 and more–3 points). Results: At the start of observation 50 patients (76%) had any kind of valvular calcification: 48 (73%) aortic valve; 47 (72%) mitral valve and 43 (66%) both valves calcification. Patients with calcified valves were older (51.2 vs. 43.7 yrs.) and had higher CACS (957 vs. 543). The time on dialysis and levels of: hemoglobin, calcium, phosphorus, iPTH, albumin, cholesterol, CRP, IL-6 as well as IMT did not differ between the groups. The median value of CCI was 4 and interquartile range 4. Only 2 (3%) patients were free of any type of cardiovascular calcification (CCI = 0), 15 (23%) patients had minimal calcification (CCI 1 to 2 points), 34 (52%) average (2–6 points) and 14 (22%) patients had severe calcification (CCI > 6). During 6-years observation period 25 (38%) patients died. The mortality rates of patients with valvular calcification was two fold higher (44%) as compared to patients without any type of valvular calcification (20%) and did not differ significantly according to affected valve: 46% vs. 17% for aortic valve and 47% vs. 16% for mitral valve. Patients with calcification of both- aortic and mitral valves had the highest mortality 55% vs. 14% as compared to whom without calcifications. In logistic regression only a Cumulative Calcification Index calculated as a combination of: number of calcified valves, CACS values, and number of calcified plaques in carotid arteries was a strong and independent predictor of mortality in this group of patients with OR = 1.84 for every point (p < 0.0003). Conclusions: Vascular but also valvular calcifications confirmed to be a strong predictor of mortality in HD patients. SAP579 EFFICACY OF THE COMBINATION OF FLEXIBLE DOSES OF PARICALCITOL AND CINACALCET IN THE TREATMENT OF MODERATE TO SEVERE SECONDARY HYPERPARATHYROIDISM IN HEMODIALYSIS PATIENTS. German Perez-Suarez German Perez-Suarez 1Avericum Hemodialysis Center. Las Palmas.Spain Eduardo Baamonde Eduardo Baamonde 2Centro Hemodiálisis Avericum Elvira Bosch Elvira Bosch 1Avericum Hemodialysis Center. Las Palmas.Spain Jose Ignacio Ramirez Jose Ignacio Ramirez 1Avericum Hemodialysis Center. Las Palmas.Spain Bilal El Hayek Bilal El Hayek 3Avericum Hemodialysis Center, Las Palmas, Spain Maria Del Mar Lago Maria Del Mar Lago 4Hospital Universitario Insular de Gran Canaria.Las Palmas.Spain Cesar Garcia Cesar Garcia 4Hospital Universitario Insular de Gran Canaria.Las Palmas.Spain Maria Dolores Checa Maria Dolores Checa 4Hospital Universitario Insular de Gran Canaria.Las Palmas.Spain Abstract Introduction and Aims: The current management of secondary hyperparathyroidism in dialysis patients is mainly with use of phosphate binders, vitamin D analogs and/or calcimimetic. Combined therapy with Cinacalcet and low doses of Paricalcitol has shown improved achievement of the biochemical targets for bone and mineral disorder (MBD) recommended by the KDOQI guidelines in dialysis patients with moderate to severe secondary hyperparathyroidism. The aim of the current study was to determine the long time effect of flexible doses of Paricalcitol and Cinacalcet combination in the parathyroid hormone (iPTH) and calcium-phosphorus product (Ca x P) in hemodialysis patients with moderate to severe secondary hyperparathyroidism. Methods: Forty eight patients (male 60% and mean age of 58 ± 16 years) with moderate to severe secondary hyperparathyroidism (mean iPTH (727 ± 352pg/mL) and Ca x P < 55, received combined treatment with flexible dose of Paricalcitol (mean dose of 9.4 mg/week) and Cinacalcet (mean dose of 38.5 mg/day). Clinical and demographic data and biochemical parameters of MBD were recorded (iPTH, calcium, phosphorus and Ca x P). In addition, we recorded all attached medication at the beginning and during follow-up (mean 17 ± 11month). Results: Three months after treatment started a reduction in iPTH levels were observed (727 ± 352pg/mL to 509 ± 281pg/mL, P < 0.000) and this decline persisted at first year of combined treatment, being the reduction of 40.7% (727 ± 352pg/mL to 431 ± 144pg/mL, P < 0,000). Also, at 1 year Phosphorus decreased (-9%, 5.2 ± 1.2mg/dl to 4.7 ± 0.9 mg/dl, P=0,048), Calcium (-1%, 9.1 ± 0.7mg/dl to 9.0 ± 0.6mg/dl, P=N/S) and Ca x P (-3%, 47.1 ± 10 mg/dl to 45.9 ± 13mg/dl, P=N/S). Non calcium-containing phosphate-binding doses increased (Sevelamer hydrochloride 3040 mg/day to 3304 mg/day, (P=N/S); lanthanum carbonate 2210mg/día to 2676mg/day P=N/S), while calcium-containing phosphate-binding doses decreased (2812 mg/day to 2058 mg/day, P=N/S). Finally, we observed a reduction of erythropoiesis stimulating agents doses (P=0.08). One patient need a parathyroidectomy and an episode of symptomatic hypocalcemia was recorded. Conclusions: Combined therapy with flexible doses of Paricalcitol and Cinacalcet in dialysis patients with moderate to severe secondary hyperparathyroidism is capable of producing a sustained decline in iPTH and serum phosphorus without increasing others biochemical parameters of MBD. SAP580 CLINICO-HISTOLOGIC EVALUATION OF PATIENTS WITH UREMIC TUMORAL CALCINOSIS RECEIVING HEMODIALYSIS Rikako Hiramatsu Rikako Hiramatsu 1Toranomon Hospital,Tokyo,Japan Yoshifumi Ubara Yoshifumi Ubara 1Toranomon Hospital,Tokyo,Japan Abstract Introduction and Aims: Uremic tumoral calcinosis (UTC) is a rare complication in patients undergoing hemodialysis (HD) and its clinical manifestations are poorly understood. This study aimed to analyze a series of UTC and investigate its clinical manifestations and pathological features. Methods: A series of 8 HD patients (1 male and 7 females; age, 41 - 75 years) with UTC, who visited our hospital between 1999 and 2011 were retrospectively analyzed. Clinical fetures, such as sex, etiology of chronic kidney failure, duration of dialyasis, location and size of UTC, and clinical evolution were analyzed. Pathogenesis of UTC was evaluated on the basis of serum calcium and phosphorus, parathyroid hormone (PTH). Histological examination was performed in all cases. Results: HD duration was 6 years or shorter in 87.5%. The primary disease was chronic glomerulonephritis in 75%. Calcification was observed in about 75% of large joints, such as hips, wrist and shoulders. Mean serum adjusted Ca and P were 10.7 ± 0.6 mg/dl and 7.0 ± 1.1 mg/dl, and the mean Ca x P was 72 ± 11.7 mg2/dl2. Mean serum CRP was 1.46 ± 2.1 mg/dl. Intact-PTH (iPTH) was 247 ± 325 pg/ml, and iPTH higher than 500 pg/ml (high iPTH) was observed in 3 cases suggesting secondary hyperparathyroidism. Low iPTH (iPTH < 100 pg/ml) was seen in 3 cases (2 cases were post-parathyroidectomy, and another was diabetic). All cases with high iPTH showed positive CRP. Clinically, in cases with high PTH, large symptomatic tumors of 5 to 10 cm were seen in the soft tissues near major joints, such as the hip, shoulder, elbow. On the other hands, in cases with low PTH, bilateral small tumors of less than 1 cm were found in the phalangeal joint and Achilles' tendon. Massive vascular calcification was seen in all cases with low PTH, while no vascular calcification was seen in cases with high PTH. In cases with high iPTH, parathyroidectomy with Ca x P control eliminated UTC and CRP became negative. Biopsy revealed only amorphous calcified material were observed in 75%, while the remaining two cases showed ectopic bone tissue with positive CRP and fibrous bone. Of the 5 cases undergoing right iliac bone biopsy, there were 2 high iPTH cases with osteitis and 3 low iPTH cases with adynamic bone. Conclusions: UTC was observed around large joints in cases with short HD duration and high Ca x P with hyperphosphatemia, not necessarily related to hyperparathyroidism. Parathyroid hyperfunction may contribute to large tumoral calcinosis. Serum CRP was positive in cases with secondary hyperparathyroidism, which suggested that tumoral calcinosis induced an inflammatory reaction that in turn led to ectopic bone formation. It is conceivable that different onset mechanisms and factors other than Ca x P and iPTH are involved in UTC. SAP581 EFFICACY, TOLERABILITY, SAFETY PROFILE AND SATISFACTION DEGREE WITH CALCIUM ACETATE AND MAGNESIUM CARBONATE TREATMENT IN HEMODIALYSIS Karla Salas Karla Salas 1Servei Nefrologia. Hospital de Terrassa. Consorci Sanitari Terrassa (Cst) Esteve Simo Vicent Esteve Simo Vicent 2Servei de Nefrologia. Hospital de Terrassa. Consorci Sanitari Terrassa. Barcelona Juan Carlos Gonzalez Oliva Juan Carlos Gonzalez Oliva 3Servei Nefrologia. Hospital de Mollet * (Barcelona) Miquel Fulquet Miquel Fulquet 4Servei Nefrologia. Hospital de Terrassa. Consorci Sanitari Terrassa (Cst). (Barcelona) Veronica Duarte Veronica Duarte 4Servei Nefrologia. Hospital de Terrassa. Consorci Sanitari Terrassa (Cst). (Barcelona) Monica Pou Monica Pou 4Servei Nefrologia. Hospital de Terrassa. Consorci Sanitari Terrassa (Cst). (Barcelona) Anna Saurina Anna Saurina 4Servei Nefrologia. Hospital de Terrassa. Consorci Sanitari Terrassa (Cst). (Barcelona) Javier Macías Javier Macías 4Servei Nefrologia. Hospital de Terrassa. Consorci Sanitari Terrassa (Cst). (Barcelona) Manel Ramírez de Arellano Manel Ramírez de Arellano 4Servei Nefrologia. Hospital de Terrassa. Consorci Sanitari Terrassa (Cst). (Barcelona) Abstract Introduction and Aims: Adequate phosphate levels results of vital importance in patients on hemodialysis (HD). Recently a new phosphate binder based on the combination of calcium acetate and magnesium carbonate (Ac/CaMg) is available. This combination provides a lower amount of calcium and a potential beneficial effect in the regulation of parathyroid hormone-mediated Mg.The aim of this study was to analyze the effectiveness, gastrointestinal tolerability, safety profile and satisfaction degree of the Ac/CaMg to control maintained hyperphosphatemia in HD. Methods: A 3 months prospective observational study in two hospitals with patients initiating Ac/CaMg treatment.Analyzed data:1.-CKD-MBD biochemical data.2.-Gastrointestinal Simptoms Rating Scale (GSRS) and Gastro Intestinal Quality of Life Index(GIQLI).3.-Safety profile: ECG register.4.-Satisfaction degree: calibrated visual analogue scale (VAS ). Results: 134 HD.26 included (20%); 13 men.4 excluded (2 exitus,1 kidney trasplant,1 digestive intolerance).Mean age 67.9 aãos and 45.8 mean time months on HD.Main aethiologies ESRD:HBP (32%) and DM (18%).CKD-MBD biochemical data (initial vs final): Ca 8.9 ± 0.5 vs 8.8 ± 0.6 mg/dl, P 4.5 ± 1.4 vs 4.1 ± 0.8 mg/dl (p < 0.1), iPTH 157.5 ± 106.1 vs 143.5 ± 94.1 pg/ml, Mg 2.1 ± 0.7 vs 2.4 ± 0.5mg/dl (p < 0.1), 25OHvitD 32.7 ± 20.8 vs 37.1 ± 22.5 ng/ml. No hypermagnesemia or ECG disorders were observed. A better digestive tolerance was observed at the end of the study (GSRS* 7.6 ± 5.7 vs 5.7 ± 3.6 simptoms,*p < 0.05; QIGLI 133.3 ± 10.9 vs 137.2 ± 10.9 points). Mean satisfaction degree: 8.5 ± 1.1 points.The mean Ac/CaMg tablet's number was 3.2 tabl/day. There were no relevant changes in relation to the number (4.9 vs 4.3 P binders/patient) and group of phosphate binders, CKD-MBD related agents, gastrointestinal medication or HD characteristics sessions. Conclusions: 1.-The new phosphate binder based on the combination of calcium acetate and magnesium carbonate is effective, well tolerated, satisfactory accepted and safe to the gastrointestinal tract in order to control maintained hyperphosphatemia in HD patients. SAP582 CALCIUM ACETATE/ MAGNESIUM CARBONATE THERAPY IS ASSOCIATED WITH LOWER PROGRESSION OF LEFT VENTRICULAR MASS INDEX AND VALVULAR CALCIFICATIONS IN HAEMODIALYSIS PATIENTS Patricia Matias Patricia Matias 1Nephrocare - Vila Franca de Xira, Vila Franca de Xira, Portugal Cristina Jorge Cristina Jorge 1Nephrocare - Vila Franca de Xira, Vila Franca de Xira, Portugal Marco Mendes Marco Mendes 1Nephrocare - Vila Franca de Xira, Vila Franca de Xira, Portugal Tiago Amaral Tiago Amaral 1Nephrocare - Vila Franca de Xira, Vila Franca de Xira, Portugal Carina Ferreira Carina Ferreira 1Nephrocare - Vila Franca de Xira, Vila Franca de Xira, Portugal Inês Aires Inês Aires 1Nephrocare - Vila Franca de Xira, Vila Franca de Xira, Portugal Célia Gil Célia Gil 1Nephrocare - Vila Franca de Xira, Vila Franca de Xira, Portugal Aníbal Ferreira Aníbal Ferreira 1Nephrocare - Vila Franca de Xira, Vila Franca de Xira, Portugal Abstract Introduction and Aims: Hypomagnesemia seems to play a role in the pathogenesis of arterial hypertension, endothelial dysfunction and vascular calcifications in dialysis patients. The aim of this study was to evaluate the relationship between calcium acetate/magnesium carbonate (CaMg) therapy and cardiovascular risk markers like pulse pressure (PP), left ventricular mass index (LVMI) and valvular calcifications in chronic haemodialysis (HD) patients. Methods: Baseline demographic, clinical, biochemical and ecocardiographic parameters were evaluated and repeated after a 24-month period. Patients started CaMg therapy during the study and were under this phosphate binder for at least 18 months. We studied 206 HD patients with mean age ( ± SD) of 63.6 ± 14.3 years, 45% female, 26% diabetics, with mean HD time of 42.3 ± 38.6 months. All patients were under post dilution hemodiafiltration with a dialysate Mg concentration of 0.5 mmol/L. Results: Forty patients were under CaMg therapy, 52 patients under sevelamer (Sev) and 114 were not taking phosphate binders (nPB). Patients taking CaMg presented higher Mg serum levels compared with the other 2 groups (CaMg: 0.94 ± 0.12 vs Sev: 0.91 ± 0.10 vs nPB: 0.82 ± 0.13 mmol/L, p < 0.001). Patients under CaMg presented a reduction of PP (p < 0.001) and LMVI (p = 0.003) at the end of the study. A stabilization of both mitral and aortic valvular calcifications was observed in the patients taking either CaMg or sevelamer, in contrast with the progression of valvular calcifications that was seen in those not taking phosphate binders (p = 0.02). Conclusions: In this 24-month study in our group of prevalent HD patients, the use of phosphate binders like CaMg or sevelamer was associated with a stabilization of valvular calcifications, but only CaMg medicated patients showed a reduction of PP and LVMI. These results should be confirmed in randomized controlled trials. SAP583 CALCIUM ACETATE AND MAGNESIUM CARBONATE ASSOCIATION: A GOOD ALTERNATIVE OF CALCIUM-BASED PHOSPHATE BINDERS Francesc Maduell Francesc Maduell 1Hospital Clinic,Barcelona,Spain Nuria Perez Nuria Perez 2Hospital Clinic, Barcelona, Spain Nuria Perez Nuria Perez 3Hospital Clinic Barcelona Marta Arias Marta Arias 3Hospital Clinic Barcelona Nestor Fontsere Nestor Fontsere 3Hospital Clinic Barcelona Manel Vera Manel Vera 2Hospital Clinic, Barcelona, Spain Montserrat Carrera Montserrat Carrera 2Hospital Clinic, Barcelona, Spain Alexis Sentis Alexis Sentis 2Hospital Clinic, Barcelona, Spain Nestor Rodriguez Nestor Rodriguez 2Hospital Clinic, Barcelona, Spain Carola Arcal Carola Arcal 2Hospital Clinic, Barcelona, Spain Josep Maria Campistol Josep Maria Campistol 2Hospital Clinic, Barcelona, Spain Abstract Introduction and Aims: Patients with chronic kidney failure tend to have cardiovascular calcification and are therefore exposed to fatal events. The two main phosphate binder groups have few disadvantages such as increased risk of hypercalcemia, which is dose dependent, in calcium-containing phosphate binders or been too expensive in the case of calcium-free phosphate binders. The aim of this study was to replace calcium phosphate-based binders with calcium acetate and magnesium carbonate association (with lower amount of calcium) to assess the calcium intake and the clinical effect on calcium (Ca), phosphorus (P) and magnesium (Mg). Methods: Prospective study with 51 patients, 31 men and 20 women, 58.5 ± 14 years, in regular dialysis program. Quarterly monitoring for 12 months, ending 24 patients. Calcium phosphate-based binders were replaced by calcium acetate and magnesium carbonate association. The remaining dialysis parameters did not change: dialyzer, monitor, dialysis time (Td), blood flow and dialysis flow. Predialysis Ca, phosphorus (P), PTH, alkaline phosphatase (AF) and Mg were determined and related medication was recorded (calcimimetics, paricalcitol and phosphate binders) as well as possible side effects. Results: 43% took calcium acetate, 49% were taking calcium carbonate at the beginning of the study and the rest of the patients (8%) started treatment de novo. The calcium intake was reduced from 1052 ± 1023 mg (baseline) to 344 ± 191 (p < 0.001) at 12 months. 47% of patients continued treatment for 12 months. The reasons for dropouts were transplants 7.8%, transfers 7.8%, suspension of HD 2%, exitus 5.9%, 17.6% suspension of phosphate binders (increased Td), 9.8% for gastrointestinal intolerance and 2% for hypercalcaemia. No differences were observed between baseline and 12 months Ca 8.75 ± 0.8 vs 8.86 ± 0.7, P 5.23 ± 1.01 vs 4.85 ± 1.6, PTH 313 ± 315 vs 255 ± 186 or AF 254 ± 165 vs 216 ± 120. The baseline Mg 2.24 ± 0.3 increased to 2.5 ± 0.3 (p < 0.011) at 12 months without a single case of hypermagnesemia that forced the suspension of the drug. No significant differences in initial doses of Osvaren, Zemplar or Mimpara and at 12 months. The dialysis dose did not change: Kt 63.6 ± 13 (basal) and 65.5 ± 13 (12 months). Conclusions: The change of calcium-based phosphate binders for calcium plus magnesium association represents a 66% reduction of calcium intake while maintaining control of Ca, P and PTH. The Mg increased slightly within the tolerable range. SAP584 IS THERE ANY CORRELATION BETWEEN CARDIAC VALVE CALCIFICATION AND ABDOMINAL AORTIC CALCIFICATION IN HEMODIALYSIS PATIENTS? Saimir Seferi Saimir Seferi 1University Hospital Center "Mother Teresa", Department of Nephrology- Dialysis- Transplantation, Tirana, Albania Merita Rroji Merita Rroji 2University Hospital Center "Motherteresa", Department of Nephrology- Dialysis- Transplantation, Tirana, Albania Eriola Likaj Eriola Likaj 2University Hospital Center "Motherteresa", Department of Nephrology- Dialysis- Transplantation, Tirana, Albania Elizana Petrela Elizana Petrela 3University Hospital Center "Motherteresa", Department of Statistic, Tirana, Albania Myftar Barbullushi Myftar Barbullushi 2University Hospital Center "Motherteresa", Department of Nephrology- Dialysis- Transplantation, Tirana, Albania Nereida Zeneli Nereida Zeneli 2University Hospital Center "Motherteresa", Department of Nephrology- Dialysis- Transplantation, Tirana, Albania Suela Mumajesi Suela Mumajesi 2University Hospital Center "Motherteresa", Department of Nephrology- Dialysis- Transplantation, Tirana, Albania Nestor Thereska Nestor Thereska 2University Hospital Center "Motherteresa", Department of Nephrology- Dialysis- Transplantation, Tirana, Albania Abstract Introduction and Aims: Vessel and valve calcification are highly prevalent in dialysis patients, which places them at high risk of cardiovascular morbidity and mortality. The use of simple and inexpensive methods to evaluate cardiovascular calcifications is preferred. The aim of this study was to evaluate the relationship of aortic and mitral valve calcification with abdominal aortic calcification. Methods: We performed a cross-sectional study with 51 hemodialysis patients. Patients were 43.5 ± 11 years of age, 42.5% males, 10.8% diabetics and the mean dialysis vintage was 45.8 ± 40.2 months. Calcification of the aortic and mitral valves was assessed by echocardiography. Echocardiograms were graded as 0–2 for absence or presence of calcification of the mitral and aortic valve. Plain X-ray images of lateral lumbar spine from all subjects were studied for calculation of semiquantitative vascular calcification scores as described by Kauppila. The severity of the anterior and posterior aortic wall calcification were graded individually on a 0- 3 scale for each lumbar segment and the results were summarized to develop a score (range 0- 24). Results: Calcification of the mitral valve was present in 16 patients (31.3%) and calcification of the aortic valve in 12 patients (23.5%). 3 patients had calcification of the both valves and 25 (49%) had a valve calcification (Vc) score = 1. Kauppila scores revealed 40 patients (78.5%) with abdominal aortic calcifications (AAC) and 26 patients (50.9%) with scores higher than 7. The mean ( ± sd) AAC score of the study population was 5.82 ± 4.08. We found that AAC score increased significantly in patients with Vc score = 1 comparing with patients without valve calcification Vc score = 0 ( Chi-square test P < 0.001). Furthermore, we found that Vc score increased significantly in patients with AAC score = 7 comparing with patients with AAC score 1-6 (Fisher's Exact Test, P < 0.001). Conclusions: Our results show that cardiac valve calcification it is strongly associated with abdominal aortic calcification in hemodialysis patients. Simple and inexpensive office-based methods such as echocardiograms or plan X-ray are widely available and can be used to provide important information about cardiovascular calcifications that may be relevant for guiding therapeutic intervention in dialysis patients. SAP585 HISTOLOGY AMD IMMUNOCHEMISTRY OF PARATHYROID GLANDS IN HEMODIALYSIS PATIENTS REFRACTORY TO CONVENTIONAL OR CINCALCET THERAPY Carlo Vulpio Carlo Vulpio 1Catholic University Maurizio Bossola Maurizio Bossola 2Chatolic University Rome Egidio Stigliano Egidio Stigliano 2Chatolic University Rome Guido Fadda Guido Fadda 2Chatolic University Rome Abstract Introduction and Aims: Data on the effect of cinacalcet on parathyroid glands (PTG) volume estimated by ultrasonography in chronic hemodialysis patients (HDP) with secondary hyperparathyroidism (SHPT) are conflicting and inconclusive. In addition, there are few data about the histopathological alterations of hyperplastic PTG in patients with SHPT after administration of cinacalcet.( ). We compared the macroscopic, microscopic and immunoistochemistry characteristics of PTG in HDP with severe SHPT who underwent parathyroidectomy (PTx) and received or not cinacalcet treatment before surgery. Methods: Twenty five consecutive HDP were included in the study: 13 (Group A; 48 PTGs) received conventional medical treatment (calcium supplements, phosphate binders and active vitamin D analogues) without cinacalcet for 13.6 ± 3.9 months and 12 (Group B; 44 PTGs) received conventional medical treatment in combination with cinacalcet for 15.3 ± 4.2 months. The number, weight and maximum longitudinal diameter (MLD) of all PTGs was measured just after PTx. We also measured the percentage of principal, oxyphil and water cells, evaluated semi-quantitatively the presence of cystic and hemorrhagic areas and defined the type of PTG hyperplasia (nodular or diffuse). Five out of 13 HDP of group A and 5 of 12 HDP of group B have been randomly selected for immunohistochemistry studies: TUNEL, Ki67, CaSR (Calcium sensing Receptors), VDR (Vitamin D receptor), VEGF (vascular endothelial growth factor). Results: The demographic, clinical and laboratory characteristics of two groups were similar. The macroscopic and microscopic characteristics are shown in the Table. The TUNEL and the Ki67, CaSR, VDR and VEGF expression was similar in the two groups.9 Table 1.     Conclusions: Macroscopic, microscopic and immunohistochemistry characteristics of HD patients with SHPT who underwent PTx and received or not received cinalcalcet before surgery did not differ significantly. SAP586 INFLUENCE OF PARATHYROIDECTOMY ON MORTALITY IN HEMODIALYSIS PATIENTS. Ana Paula Santana Gueiros Ana Paula Santana Gueiros 1Ufpe, Recife, Brazil Joaquim Oliveira Borba Junior Joaquim Oliveira Borba Junior 1Ufpe, Recife, Brazil Andrea Bezerra de Melo Da Silveira Lordsllen Andrea Bezerra de Melo Da Silveira Lordsllen 1Ufpe, Recife, Brazil José Edevanilson de Barros Gueiros José Edevanilson de Barros Gueiros 1Ufpe, Recife, Brazil Abstract Introduction and Aims: Chronic kidney disease-mineral bone disorder (CKD-MBD) is highly prevalent among patients with end-stage renal disease and has been linked to a higher risk of death. The objective of the present study was to evaluate predictors of death risk in a group of patients with CKD-MBD. Methods: We performed a retrospective analysis of 124 hemodialysis patients followed in CKD-MDB Clinic of our institution, from March 1, 2004 to January 31, 2008. Patients included in this study were followed-up until March 31, 2010. The patients were divided into two groups: surviving and No-surviving. The groups were compared in terms of age, sex, duration of dialysis, occurrence of vascular calcification, parathyroidectomy (PTX), serum parathyroid hormone (PTH), calcium, phosphate and alkaline phosphatase. All PTX were performed in follow-up period. Patients who did not undergo PTX were defined as No-PTX. Results: The mean period of follow-up was 3.6 years (73 days- 6 years). The incidence of death was 5.4 per 100 patients/year; 95% CI: 3.48- 7.89. Cardiovascular disease was the major cause of death (56%). The six-year survival rate was 52.1%. The prevalence of diabetics was 4.8%. The baseline characteristics of the patients are presented in table.10 Table 1.     *mean ± standard deviation, # median and interquartiles range (P25;P75) PTX was performed in 35.7% and 17.4% of the surviving and No-surviving patients, respectively (p = 0.091). In the univariate analysis, age (hazard ratio–HR = 1.04; 95% CI: 1.00-1.08; p = 0.031) and No-PTX (hazard ratio - HR 3.13; 95% CI: 1.04-9.4; p = 0.041) were associated with the risk of mortality. After adjustment, a Cox regression multivariate analysis showed that variables associated independently with death were No-PTX (HR = 4.19, CI 1.22-14.5, p = 0.023) and age (HR = 1.04, CI 1-1.09, p = 0.029). Patients who did not undergo PTX presented a poorer survival compared to patients who did undergo PTX (p = 0.03) Conclusions: This result suggests that a more aggressive treatment of secondary hyperparathyroidism could decrease mortality in the high risk population. SAP587 ARE THE PARATHYROID HORMONE LEVELS IN JAPANESE HEMODIALYSIS PATIENTS UNDERESTIMATED? - SPECULATION FROM A SINGLE CENTER EXPERIENCE Noritomo Itami Noritomo Itami 1Kidney Center ,Nikko Memorial Hospital-Higasimuroran Satellite Clinic Kazushi Tuneyama Kazushi Tuneyama 2Idney Center ,Nikko Memorial Hospital-Higasimuroran Satellite Clinic Susumu Uemura Susumu Uemura 2Idney Center ,Nikko Memorial Hospital-Higasimuroran Satellite Clinic Hiromi Hamada Hiromi Hamada 3Kidney Center,Nikko Memorial Hospital -Higashi-Muroran Satellite Clinic Jouji Takada Jouji Takada 2Idney Center ,Nikko Memorial Hospital-Higasimuroran Satellite Clinic Kunihiko Takahashi Kunihiko Takahashi 4Kidney Center, Nikko Memorial Hospital-Higashimuroran Satellite Clinic Abstract Introduction and Aims: In Japan more than half of the dialysis centers belong to small clinics. Such clinics, including ours, do not have laboratories. Nurses and clinical engineers are busy preparing to start hemodialysis (HD). After blood samples are drawn, most are left at room temperature except for samples requiring special care such as cooling, until they can be picked up by an outside laboratory in a few hours or on demand by telephone, and samples that are centrifuged immediately and sera frozen until measured. Blood samples for parathyroid hormone(PTH) are collected in a similar fashion, although some laboratories recommend that it is desirable to separate the sera within 2 hours for measurement of the serum intact PTH. Little attention has been paid to the handling of the samples before centrifuging. We evaluated the difference of serum intact PTH levels between sera at the time they were drawn and sera 2 hours after drawing. Methods: After taking informed consent, we studied 120 patients (69 men, 51 women) on HD in a single center. Mean age was 66.1 ± 12.4 years, 38 patients (32%) had diabetes. Dialysis vintage was 8.2 ± 7.8years. Blood samples were drawn before the HD session into vacutainer tubes with separator (Clot tuber super, Tokyo, Japan) one sample (Group A) was centrifuged (5 minutes, 3000 rpm) immediately after clotting and another sample from the same patient (Group B) was centrifuged 2 hours after being drawn and left at room temperature. After that, sera were sent to the laboratory and stored at -20°C until the time of assay. Ten serum samples of Group A were measured at 1 hour, 2 hours, 4 hours and 8 hours. Intact PTH was determined by chemiluminescent enzyme immunoassay using Beckman- Coulter Access Intact PTH assay. Results: Serum Intact PTH levels from Group A were 140.6 ± 140pg/ml and 122.5 ± 126pg/ml in Group B (not significant). The values in Group B were 14.6 ± 13% lower than those in Group A. According to the KDOQI target range (150-300pg /ml), 14 patients(11.7%) were classified differently: 9 patients with Group A samples in the target range had Group B samples lower than the target range. Another 5 patients with A Group samples higher than the target range had B Group samples within the target range. Conclusions: In the Japanese CKD-MBD guideline, the target range of PTH is lower than that of KDOQI. This may be affected by the handling of blood samples in the pre-analytic period. A guideline is needed to define the handling of PTH samples in order to manage the CKD- MBD problem in HD patients properly. SAP588 IMPACT OF RENAL TRANSPLANT ON CORONARY ARTERY CALCIFICATION IN HEMODIALYSIS PATIENTS Konstantinos Adamidis Konstantinos Adamidis 1Nephrology Department, Evangelismos General Hospital, Athens, Greece Theophanis Apostolou Theophanis Apostolou 1Nephrology Department, Evangelismos General Hospital, Athens, Greece Christos Pleros Christos Pleros 1Nephrology Department, Evangelismos General Hospital, Athens, Greece Theodora Oikonomaki Theodora Oikonomaki 1Nephrology Department, Evangelismos General Hospital, Athens, Greece Eirini Kyratzi Eirini Kyratzi 2Radiology Department, Evangelismos General Hospital, Athens, Greece Dimitrios Exarchos Dimitrios Exarchos 2Radiology Department, Evangelismos General Hospital, Athens, Greece Georgios Metaxatos Georgios Metaxatos 1Nephrology Department, Evangelismos General Hospital, Athens, Greece Spyros Dracopoulos Spyros Dracopoulos 3Renal Transplant Unit, Evangelismos General Hospital, Athens, Greece Nikoletta Nikolopoulou Nikoletta Nikolopoulou 1Nephrology Department, Evangelismos General Hospital, Athens, Greece Theophanis Apostolou Theophanis Apostolou 1Nephrology Department, Evangelismos General Hospital, Athens, Greece Abstract Introduction and Aims:Vascular calcifications as a manifestation of chronic kidney disease-mineral bone disorders (CKD-MBD) consists a strong predictor of cardiovascular and all-cause mortality. The aim of this study was to evaluate the coronary artery calcification (CAC) in patients with end stage renal disease (ESRD) undergoing regular hemodialysis (HD) and determine the effect of renal transplant (RT) in the progression of CAC. Methods: The study included 20 patients with ESRD undergoing a regular HD treatment (16 males, 4 females) 54.1 ± 9.5 years old who had just received a RT and 16 more HD patients (11 males, 5 females) of 54.4 ± 13.8 years old as control group. At the time of the study all patients were on HD 4 hours thrice a week for 56 ± 34 months. Initially, for the evaluation of CAC, all patients underwent a baseline multislice spiral coronary computed tomography (MSCT) using the Agatston technique for calcium scoring (CS). Baseline MSCT in the RT group was performed immediately after transplantation. Parathyroid hormone, Ca, P, Ca x P, Mg, LDL and HDL cholesterol, and CRP were measured in all patients. After a mean follow up of 16 ± 4 months, 18 RT patients and 14 HD patients underwent a second MSCT in order to evaluate the progression of CAC. Results: Nearly all patients suffered from severe CAC. The baseline CS which was very high, was positively correlated with age (p < 0,001) and CRP (p = 0.03) but no significant association was found between baseline CS and the measured laboratory values. In HD patients, follow-up CS was significantly increased (p = 0.028), whereas RT group did not show significant change. The rate of CS progression was significantly slower in RT group than in HD group (p = 0.05). Conclusions: The prevalence of CAC in these HD patients was very high and progressed during time and mostly associated with age and CRP. Renal transplantation and recovery of renal function considerably halted CAC progression, probably because of the elimination of uremic burden, a significant factor in CKD-MBD disorder that promotes vascular calcifications. SAP589 OBSERVATIONAL PROSPECTIVE STUDY ON INCIDENT HAEMODIALYSIS PATIENTS: VDRA USE AND IMPACT ON SURVIVAL: RESULTS OF THE FARO-2 COHORT Piergiorgio Messa Piergiorgio Messa 1Fondazione Irccs Ca' Granda Policlinico Milan Italy Mario Cozzolino Mario Cozzolino 2Ospedale S. Paolo Milan Ita Sandro Mazzaferro Sandro Mazzaferro 3Università La Sapienza Roma Ita Diego Brancaccio Diego Brancaccio 2Ospedale S. Paolo Milan Ita Giuseppe Cannella Giuseppe Cannella 4Ospedale S. Martino Genova Ita Abstract Introduction and Aims: End-stage renal disease is growing in prevalence and incidence and mortality rates among patients undergoing hemodialysis at every age exceed the rates among those not undergoing hemodialysis. Vitamin D Receptor Activators (VDRA) effectively suppresses parathyroid hormone secretion and there are an increasing number of observational studies indicating survival advantages of VDRA in CKD patients. Otherwise there are few studies on incident patients on hemodialysis. FARO 2 is an Italian study on this population to evaluate the adherence to the K-DOQI guidelines and the outcomes in newly haemodialysis patients Methods: FARO2 was a longitudinal perspective observational study performed in 26 Italian dialysis centers. It evaluates incident HD patients and follows them every 6 months for a maximum of 36 months. Data were collected using a questionnaire with clinical, biochemical and therapeutic parameters obtained for each patient Results: A total of 568 patients were observed: levels of serum PTH (median values at 6 months vs 36 months; 225 vs 254 pg/ml) and Ca (8.8 vs 8.9 mg/dl) did not significantly change; levels of P were decreased at 36 months (5.1 vs 4.8 mg/dl). Over the course of the survey, there was an increase in the use of VDRA (from 46% at 6 months to 54.7% at 36 months, p < 0.001). There were not substantial difference in comorbidities at baseline between the group treated with VDRA (67% male; median age 69 years) vs the group not treated (70% male; median age 70 years)11 Table 1.         Survival probability at 24 months was 74.5 % (95%CI: 70.2-78.3). Kaplan-Meier survival analysis showed a significant increase in survival in patients who received vitamin D supplementation compared to those without (p < 0.01). Conclusions: Findings from our analysis of the FARO2 study indicate that patients were well-controlled for PTH, Ca and P during the observation period. In addition, patients receiving vitamin-D receptor activators were associated with increased survival over those without. SAP590 COMPLIANCE OF THE HEMODIALYSIS PATIENT TO THE NATIVE VITAMIN D THERAPY Pierre Delanaye Pierre Delanaye 1University of Liège Bernard Dubois Bernard Dubois 1University of Liège Jean-Marie Krzesinski Jean-Marie Krzesinski 1University of Liège Etienne Cavalier Etienne Cavalier 1University of Liège Abstract Introduction and Aims: Drug compliance of the dialysis patient is often considered as poor, notably because these patients are old, severely ill and treated by many different therapies. However, identification of the lack of compliance in patients is not so easy. Nowadays, it is recommended to give native vitamin D to dialysis patients. As this therapy may be closely monitored by 25-OH vitamin D plasma measurement, it could be a simple model to assess patients' compliance. Methods: In December 2010, we decided to give our patients cholecalciferol during a dialysis session in place of taking it at home. Majority of these patients got 25,000 IU of cholecalciferol once a week. We analyzed patients who received stable doses of vitamin D, 5 months before and after the modification in prescription (n = 38). The 25-OH vitamin D plasma levels were measured three times before and after the modification in administering (within a six weeks interval). The Diasorin Liaison method was used. We separately analyzed the group of patients whose 25-OH vitamin D levels remained under 30 ng/mL. Results: In the global population, mean concentration of 25-OH vitamin D levels increased from 26 ± 12, 25 ± 12, 30 ± 12 ng/mL when therapy was taken at home to 36 ± 12, 36 ± 10, 39 ± 10 ng/mL when it was given during one dialysis session per week. If we analyzed the 17 patients (45%) with 25-OH vitamin D levels under 30 ng/mL (19 ± 7 ng/mL) before changing the administering procedure, we observed a continuous and very significant increase in 25-OH vitamin D levels in the three next measurement results (27 ± 6, 29 ± 6 and 32 ± 8 ng/mL). There is a strong relationship between initial 25-OH vitamin D levels and the increase observed after changing the administration mode (r=-0.6). The change of prescription was realized in December (no cutaneous synthesis in Belgium) and the improvement in 25-OH vitamin D was thus clearly not linked to seasonal variation. Conclusions: We have illustrated the lack of compliance observed in a high percentage of dialysis patients. This lack of compliance may be particularly high for native vitamin D therapy because such therapy is not daily given. Therefore, such therapy should be given during dialysis session to improve compliance. SAP591 REPERCUSSION OF CHOLECALCIFEROL SUPPLEMENTATION ON THE TREATMENT OF MINERAL METABOLISM IN HEMODIALYSIS PATIENTS. Vanesa De la Fuente Vanesa De la Fuente 1Hospital Perpetuo Socorro. Alicante. Spain Vanesa De la Fuente Vanesa De la Fuente 1Hospital Perpetuo Socorro. Alicante. Spain Maria Teresa Gil Maria Teresa Gil 1Hospital Perpetuo Socorro. Alicante. Spain Patricia Gutierrez Patricia Gutierrez 1Hospital Perpetuo Socorro. Alicante. Spain Pablo Delgado Pablo Delgado 1Hospital Perpetuo Socorro. Alicante. Spain Jorge Ribero Jorge Ribero 1Hospital Perpetuo Socorro. Alicante. Spain Lola Arenas Lola Arenas 1Hospital Perpetuo Socorro. Alicante. Spain Abstract Introduction and Aims: The aim was to evaluate the effects of oral cholecalciferol supplementation (C suppl) on the treatment of mineral metabolism (MM) in long-term hemodialysis(HD) patients. Methods: Prospective study of a cohort of 144 prevalent HD patients from a single center in Alicante (a very sunny city) during 6 months follow-up.(mean age :67.4 ± 12.3 years). Serum 25(OH)D, PTH, calcium, phosphorus and treatment of MM were measured at baseline, 3 and 6 months after C suppl. Phosphate binders, alphacalcidol, paricalcitol, calcimimetics and dialisate calcium were measured at baseline, and 6 months after C suppl. Patients with serum 25(OH)D between 20 and 30 ng/ml received 0,266 mg once a month and < 20 ng/ml twice a month. Results: Serum 25(OH)D was < 30 ng/ml in 137 patients (95.1%). There was a significant increase in 25(OH)D after C suppl (table 1). In 111 (77%) patients, 25(OH)D levels became normal ( > 30 ng/ml) at the end of the study, in comparison with only 7 (4.8%) at baseline. Only two patients achieved a toxic level of 25(OH)D: > 100 ng/ml after C suppl. There were no episodes of hypercalcemia ( > 10.5 mg/dl). 95 patients (66%) reduced PTH serum levels at 3 months. Table 2 shows the changes in the treatment after C suppl. 26 patients reduced the MM treatment, 112 of them did not change it and only 6 patients needed to increase it. No changes were made in doses of non-calcium and calcium phosphate binders. The cost of C suppl was 232.2 euros/month at the beginning and 153 euros/month at 6 months. The cost of MM treatment was reduced in 15.432 euros during the 6 month of study.1213 Table 1.     Table 2.     Conclusions: Our study confirms the high incidence of vitamin D deficiency or insufficiency in HD patients and the apparently safety and efficacy of oral C suppl. This study shows an improvement in hyperparathyroidism control after C suppl as well as the reduction of cinacalcet, active vitamin D , paricalcitol dosage and cost of the treatment. SAP592 RELATIONSHIP BETWEEN VITAMIN D ANALOGS AND LEFT VENTRICULAR MASS INDEX IN MAINTANENCE HEMODIALYSIS PATIENTS Siren Sezer Siren Sezer 1Department of Nephrology, Baskent University, Ankara, Turkey Emre Tutal Emre Tutal 1Department of Nephrology, Baskent University, Ankara, Turkey Zeynep Bal Zeynep Bal 1Department of Nephrology, Baskent University, Ankara, Turkey Mehtap Erkmen Uyar Mehtap Erkmen Uyar 2Baskent University Hospital, Department of Nephrology, Ankara, Turkey F. Nurhan Ozdemir Acar F. Nurhan Ozdemir Acar 3Department of Nephrology,Baskent University, Istanbul, Turkey Abstract Introduction and Aims: Type 4 cardiorenal syndrome is characterized by a condition of primary chronic kidney disease (CKD) contributing to decreased cardiac function, left ventricular hypertrophy (LVH). Inadequate treatment of secondary hyperparathyroidism (SHPT) has been associated with cardiovascular complications. Vitamin D receptor (VDR) activation reduces LVH progression in animal models. The aim of this study was to evaluate the effects of intravenous paricalcitol and calcitirol treatment on left ventricular mass index (LVMI) in MHD patients. Methods: This is a randomized, comparative, 12-months prospective study with intravenous paricalcitol or calcitriol treatment in MHD patients.The study were consisted of a pretreatment phase (before enrollment a 4-week wash-out period, followed by a 4 week baseline period) and tretment phase (4:1 ratio of paricalcitol to calcitriol). Serum calcium < 10.5mg/dL, serum Ca×P < 75 and PTH level = 300pg/ml were randomized to recieve either paricalcitol or calcitriol for the treatment phase. Initial paricalcitol dose was based on a baseline iPTH/150/every dialysis session. Echocardiographic findings included interventricular septal thicknes, posterior wall thickness and left ventricular internal diameter. LVMI was calculated by Devereux's Formula. Patients' antihypertensive treatments and systolic and diastolic blood pressure and interdialytic weight gain were recorded monthly to analyse the risk factors for the development of LVH. Results: 40 patients in paricalcitol group (11 female, age; 49.0 ± 12.1 yrs) and 40 subjects in calcitriol group (12 female, age; 53.3 ± 10.5 yrs) were included. Demographic and clinical (blood pressure, interdialytic weight gain) characteristics and laboratory data of two groups were similar at baseline. In paricalcitol group, mean PTH values in 1st and 12th month were 849.5 ± 325.9 pg/ml and 596.3 ± 207.3 pg/ml whereas in calcitriol group, mean PTH values in 1st and 12th month were 762.6 ± 352.8 pg/ml and 734.0 ± 326.4 pg/ml (p < 0.001). At baseline both groups' calcium, phosphorus and CaxP levels were similar however at the end of the study in paricalcitol group phosphorus and CaxP levels were significantly lower than the calcitriol group (4.7 ± 1.4; 43.13 ± 13.3 vs. 5.5 ± 1.3; 52.4 ± 13,8) (p < 0.006, p < 0.003, respectively). We found that in paricalcitol group there was no significant change in LVMI while in calcitriol group LVMI significantly increased during the follow-up period (136.0 ± 36.0 g/m2 to 132.9 ± 40.4 g/m2 vs. 139,7 ± 25,8 g/m2 to 149,4 ± 31,0 g/m2) (p < 0.044). Despite the dose of vitamin D administration was significantly higher in paricalcitol group than the calcitriol group, we observed less hypercalcemia, hyperphosphotemia and elevated CaxP in paricalcitol group (p < 0.0001). Duration of treatment interruption because of high calcium or phosphorus levels were significantly lower in paricalcitol group than calcitiriol group (1.8 ± 2.3 vs 2.5 ± 2.1 months, p < 0.023). Conclusions: Hyperparathyroidism, hypercalcemia and hyperphosphatemia are associated with increased cardiovascular mortality in patients with CKD. We found a marked difference in the ability of these two vitamin D analogs to control the SHPT. Paricalcitol treatment reduced PTH concentrations more effectively without causing hypercalcemia and hyperphosphatemia than calcitriol therapy. Paricalcitol may prove to have a substantial beneficial effect on LVH and its outcome in patients with MHD patients. SAP593 CHRONIC KIDNEY DISEASE - MINERAL BONE DISORDER EVALUATION IN PERITONEAL DIALYSIS PATIENTS Rodrigo Azevedo de Oliveira Rodrigo Azevedo de Oliveira 1Universidade de São Paulo Fellype Carvalho Barreto Fellype Carvalho Barreto 2Universidade de São Paulo, São Paulo, Brasil Monique Mendes Monique Mendes 1Universidade de São Paulo Luciene Dos Reis Luciene Dos Reis 3Sao Paulo University, Sao Paulo, Brazil Juliana Cunha Ferreira Juliana Cunha Ferreira 1Universidade de São Paulo Zita Maria Leme Britto Zita Maria Leme Britto 4Cetene Rosa Maria Moysés Rosa Maria Moysés 1Universidade de São Paulo Vanda Jorgetti Vanda Jorgetti 1Universidade de São Paulo Abstract Introduction and Aims: Chronic kidney disease—mineral bone disorder (CKD-MDB) is an important complication of dialysis population. However, few studies have evaluated this disorder in the peritoneal dialysis (PD) setting. The aim of this study was to evaluate CKD-MBD profile (laboratorial abnormalities, vascular calcification and renal osteodysthrophy) in PD patients Methods: Twenty-nine patients (15 males; age: 48.3 ± 10 years; time on PD 20 ± 18 months) were submitted to (i) laboratorial evaluation, (ii) plain x-rays of hands and hips to evaluate vascular calcification and (iii) iliac crest bone biopsy. Results: The main biochemical and histomorphometric (TMV parameters) characteristics of the study population were: ionized calcium 4.84 ± 0.35 mg/dl; phosphorus 4.9 ± 1.74 mg/dl; alkaline phosphatase: 108 ± 37.8 U/L; iPTH: 355 (75-2435) pg/ml; sclerostin: 1667.6 ± 1181.3 ng/ml; FGF-23: 494.5 (76-7122) pg/ml; 25(OH)vitamin D 12.4 ± 7.3 ng/ml. TMV Parameters: Turnover: BFR/BS 0.01 (0.001-0.1) μm3/μm2/d; Mineralization: OV/BV 3.32 ± 3.82 %; Mlt: 66.8 (83-1098) days; Volume: BV/TV: 23.1 ± 8.3 %. Vascular calcification was present in 24% of the sample. High and low turnover bone diseases were detected in 48.3% and 51.7% of the patients, respectively. Low turnover bone disease was associated to older age, shorter time on PD, lower PTH levels and vascular calcification. Bone formation rate was negatively correlated to sclerostin levels (r: -0.45; p: 0.01). All patients presented vitamin D deficiency (31 %) or insufficiency (69%) and mineralization defects. The trabecular bone volume was preserved in 70% of the patients. Conclusions: The prevalence of low and high turnover bone disease was similar in this PD population, being the former associated to vascular calcification. Sclerostin might play a part in the development of low turnover bone disease. Trabecular volume seems to be preserved in PD. SAP594 TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN MAINTANENCE HEMODIALYSIS PATIENTS: A RANDOMISED CLINICAL TRIAL COMPARING PARICALCITOL, CALCITRIOL AND SINACALCET Siren Sezer Siren Sezer 1Department of Nephrology, Baskent University, Ankara, Turkey Emre Tutal Emre Tutal 1Department of Nephrology, Baskent University, Ankara, Turkey Zeynep Bal Zeynep Bal 1Department of Nephrology, Baskent University, Ankara, Turkey Ruya Ozelsancak Ruya Ozelsancak 2Department of Nephrology, Baskent University, Adana, Turkey Bahar Gurlek Demirci Bahar Gurlek Demirci 3Department of Nephrology, Baskent University, Ankara, Turkey Dilek Torun Dilek Torun 2Department of Nephrology, Baskent University, Adana, Turkey F. Nurhan Ozdemir Acar F. Nurhan Ozdemir Acar 4Department of Nephrology,Baskent University, Istanbul, Turkey Abstract Introduction and Aims: Secondary hyperparathyroidism (SHPT) is a common complication of chronic kidney disease (CKD). For treatment of SHPT active vitamin D (calcitriol), paricalcitol and calcimimetics (sinacalcet) are widely being used in daily practice. The aim of this study is to evaluate and compare the effectiveness of these treatments as monotherapies and in combination in a group of maintenance hemodialysis (MHD) patients with SHPT Methods: This is a randomized, 12-months prospective study. Eligible 114 subjects (44 female, age; 51.6 ± 13.5 years) out of 250 MHD patients were included. After a washout period of one month, patients who were already receiving calcitrol therapy and having parathyroid hormone (PTH) levels above > 300 pg/mL were randomized and treated according to one of 4 groups: a) total serum calcium < 10.5mg/dL, serum Ca × P < 75 and PTH level between 300-1000 pg/ml were randomized to recieve either paricalcitol (n: 31, group 1) or calcitriol (n: 32, group 2), b) normalized total serum calcium > 10.5mg/dL, serum Ca × P < 75 and PTH level > 1000 pg/ml were randomized to recieve either cinacalcet plus paricalcitol (n: 29, group 3) or cinacalcet plus calcitriol (n: 22, group 4). Subjects were administered doses in a 4:1 ratio of paricalcitol to calcitriol. All patients' calcium, albumin, phosphorus levels assessed by monthly periods while iPTH levels were measured by 3 months periods. Results: Study groups were similar in means of demographic characteristics. Patients in group 3 and 4 had significantly higher Ca, P and CaxP product levels at the first 3 months of study (p < 0.01) however in following 9 months these levels were statistically similar in all groups. When PTH levels were assessed and compared to basal values we observed a significant reduction (- 9.8%) in group 1 while there was an increament in group 2 (%24.3, p < 0.008). iPTH levels of group 3 and 4 were similar at the baseline and at the 6. months evaluation however they were significantly lower in group 3 in the 9. and 12. moth evaluation (1044.3 ± 653.7 vs 1589.2 ± 379.1 and 934.3 ± 606.0 vs 1484.3 ± 626.1 pg/mL, p < 0.001, 0.016 respectively). When we compared groups 3 and 4 in means of iPTH reduction ratio at the end of 1 year group 3 had higher reduction ratios (-33.7%) compared to group 4 (-6.1%, p:0.011). The mean cinacalcet dose initiated were similar in group 3 and 4 while the mean cinacalcet dose significantly increased in patients receiving calcitriol versus paricalcitol (42.0 ± 15.2 mg and 25.2 ± 16.1 mg, p < 001). Duration of vitamin D cessation due to hypercalcemia or hyperphosphatemia was significantly longer in all calcitriol based treatment regimens (2.5 ± 2.7 vs 1.4 ± 2.1 months, p < 0.013). Conclusions: This study showed that paricalcitol treatment reduced PTH concentrations more effectively without causing hypercalcemia and hyperphosphatemia than calcitiriol therapy either alone or in combination with calcimimetics. This potent effect is even evident in patients with severe hyperparathyroidism. We suggest that paricalcitol should be prefered to calcitriol for the treatment of MHD patients with moderate to severe SHPT. Treatment sustainability with paricalcitol is significantly better than calcitriol. SAP595 FIXED DOSES OF PARICALCITOL AND CINACALCET IN THE THERAPY OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS ON MAINTENANCE DIALYSIS–OUR INITIAL EXPERIENCE Ljubisa Veljancic Ljubisa Veljancic 1Clinic of Nephrology Mma Milorad Radojevic Milorad Radojevic 1Clinic of Nephrology Mma Zoran Paunic Zoran Paunic 1Clinic of Nephrology Mma Neven Vavic Neven Vavic 1Clinic of Nephrology Mma Katarina Obrencevic Katarina Obrencevic 1Clinic of Nephrology Mma Zoran Kovacevic Zoran Kovacevic 1Clinic of Nephrology Mma Janko Pejovic Janko Pejovic 2Institute of Medical Biochemistry Mma Abstract Introduction and Aims: Newly applied medications in the therapy of secondary hyperparathyreoidism (SHPTH), like vitamin D analogues and calcimimetics, significantly increase the price of SHPTH therapy. Their administration is still limited by the possibilities and the decisions of certain insurance funds, and physicians oftenly are not in position to apply the recommended therapeutic protocol, but minimal doses of these medications, mostly as an addition to existing standard therapy. The aim of the study was to investigate the efficacy of therapeutic protocol based on administration of fixed doses of paricalcitol and calcimimetic cinacalcet compared to the standard SHPTH therapy. (diet, Ca-based phosphate binders, dialysis with appropriate Ca level in dialysate and vitamin D)–according to the EBPG and K/DOQI guidelines. Methods: Ten chronic haemodialysis patients with verified SHPTH, that were three months on standard SHPTH treating protocol, were treated during subsequent three months also with fixed doses of paricalcitol and cinacalcet in the following way: Zemplar ampoules a 2 mcg were administrated three times a week i.v. at the end of each haemodialysis, with the possibility of omitting the dose if control Ca values should seize 2,55 mmol/l (1,25 mmol Can ++ ) and/or if control phosphatemia values should exceed 1,8 mmol/l. Calcimimetic cinacalcet was administrated daily in fixed doses of 30 mcg. In the case of hypercalcemia and/or hyperphosphatemia, paricalcitol is omitted until the normalization of Ca and PO4. If the values of Ca and P04 are low or in physiologic limits despite regularly administrated 2 mcg paricalcitol/HD, calcitriol 0,25-2 mcg/week per os is added, according to the level of Ca and PO4. On the contrary, in the case of hypercalcemia and/or hyperphosphatemia, vit. D preparation is the first to be omitted, and than, if that is not enough, ampoules of paricalcitol are omitted also, until the weekly checked values of calcemia and phosphatemia are not within wanted therapeutic limits. Results: In the first or S-phase (standard therapeutic protocol) at the beginning of three-month period, mean values of iPTH, Ca, Can ++ , PO4 and alkaline phosphatase were: 912 ± 282 pg/ml; 2,30 ± 0,12 mmol/l; 1.12 ± 0,05 mmol/l; 1,42 ± 0,20 mmol/l and 507 ± 272 IU, respectively. At the end of three-month period iPTH was 779 ± 178 pg/ml. The values of Ca, Can ++ and PO4 were maintained within wanted limits by administration of averagely 0,32 ± 0,22 mcg calcitriol per os, daily. In the second or F-phase (fixed doses of paricalcitol and cinacalcet) the mean reached percentage of iPTH reduction was 49 ± 18%, vs. 16 ± 9% in the S-phase (p < 0,001). The mean percentage of alkaline phosphatase reduction in the F-phase were 35 ± 15% and in the S-phase 11 ± 7% (p < 0,001). In the F-phase, an average of 0,19 ± 0,18 mcg of calcitriol was administrated, and among 36 possible paricalcitol doses (5 mcg) per patient, an average of 31 or 86% was applied. The most frequent cause for omitting calcitriol and paricalcitol was the occurrence of hyperphospatemia and hypercalcemia (65% and 35%, respectively). + /- Conclusions: Our therapeutic protocol with fixed doses of paricalcitol and cinacalcet, in a short term appliance, is safe and efficient in lowering of serum iPTH levels without serious side effects. © The Author 2012. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com
TI - Mineral and bone disease - CKD 5D
JF - Nephrology Dialysis Transplantation
DO - 10.1093/ndt/gfs245
DA - 2012-05-01
UR - https://www.deepdyve.com/lp/oxford-university-press/mineral-and-bone-disease-ckd-5d-6H94m1UVJk
SP - ii492
EP - ii510
VL - 27
IS - suppl_2
DP - DeepDyve
ER -