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Keywords: bone markers, calcium acetate, fibroblast growthfactor-23, haemodialysis, magnesium carbonate, phosphatebinderABSTRACTBackground. Different phosphate binders exert differingeffects on bone mineral metabolism and levels of regulatinghormones. The objective of this post hoc evaluation of theCALcium acetate MAGnesium carbonate (CALMAG) studywas to compare the effects of calcium acetate/magnesium car-bonate (CaMg) and a calcium-free phosphate binder, sevela-mer-hydrochloride (HCl), on serum levels of fibroblast growthfactor-23 (FGF-23) and markers of bone turnover.Methods. This secondary analysis of the controlled, random-ized CALMAG study, comparing the effect of CaMg and seve-lamer-HCl on serum phosphorus (P), aimed to investigate theparameters described above. The analysis included 204patients who completed the initial study per protocol (CaMg,n=105; sevelamer-HCl, n=99).Results. ThestudyshowedthatserumlevelsofFGF-23weresig-nificantly reduced with CaMg and sevelamer-HCl, with nodifference between groups at Week 25 [analysis of covariance(ANCOVA); log-intact FGF-23 (iFGF-23), P=0.1573]. FGF-23levelsstronglycorrelatedwithserumPlevelsatalltimepointsinboth groups. The bone turnover parameters alkaline phospha-tase (AP), bone AP (BAP), procollagen type 1 amino-terminalpropeptide 1 (P1NP), osteoprotegerin (OPG), beta-crosslaps (β-CTX) and tartrate-resistant acid phosphatase 5b (TRAP 5b) in-creased significantly in the sevelamer-HCl group; they remainedalmostunchangedintheCaMggroup,aftertheinitialphaseofPlowering(ANCOVA,P

Background: Currently, less frequent than once-weekly subcutaneous epoetin administration regimens were shown to be equally effective and safe as once-weekly schedules in stable predialysis and peritoneal dialysis patients. Bioequivalency of once-every-2-weeks and once-weekly subcutaneous administration of the same total dose of epoetin beta for the maintenance phase of anemia treatment in stable iron-replete long-term hemodialysis patients therefore was investigated prospectively. Methods: Two hundred seven stable selected hemodialysis patients without diabetes, acute illness, significant inflammation, malnutrition or hyperparathyroidism administered once-weekly subcutaneous epoetin beta and preserving stable hemoglobin levels between 10 and 12 g/dL (100 and 120 g/L; difference between maximum and minimum of 3 subsequent levels ≤2.5 g/dL [≤25 g/L]) and optimal iron status for at least 8 weeks before inclusion were enrolled and randomly assigned to subcutaneous administration of the same total dose of epoetin beta either once every 2 weeks (group 2w; n=104) or once weekly (group 1w; n=103) for 24 weeks. Results: Per-protocol analyses (group 1w=102 versus group 2w=101) showed similar hemoglobin levels throughout the assessment period (weeks 13 to 24): mean, 11.38 g/dL; 95% confidence interval (CI), 11.23 to 11.54 versus 11.41 g/dL; 95% CI, 11.22 to 11.58. Mean difference was 0.028 g/dL (95% CI, −0.208 to 0.264) in the prespecified range (±0.5 g/dL). Epoetin dose ratio of group 2w to group 1w was 0.94 (95% CI, 0.813 to 1.076), also in the prespecified range of equivalence (0.80 to 1.25). Hemoglobin levels and epoetin doses were stable during the study irrespective of treatment schedule, with no differences between groups at any time. Both schedules were well tolerated. Conclusion: Once-every-2-weeks and once-weekly subcutaneous epoetin beta regimens are equivalent in the maintenance phase of anemia treatment in long-term stable hemodialysis patients without diabetes, with similar safety profiles.