• Michael Koch, Wolfgang Treiber, and Danilo Fliser.
• Nephrology Center, Gartenstrasse 8, 40822, Mettmann, Germany, koch@dialyse-mettmann.de.
• Clin Drug Investig. 2013 Oct 1; 33 (10): 699-706.

BackgroundCorrection of low hemoglobin (Hb) levels is associated with improved survival and greater quality of life in dialysis patients, but frequent administration of erythropoiesis stimulating agent (ESA) therapy is unsatisfactory for peritoneal dialysis patients.ObjectiveThe objective of this study was to assess Hb stability in an unselected population of maintenance peritoneal dialysis patients receiving once-monthly treatment with C.E.R.A., a continuous erythropoietin receptor activator.MethodsIn a prospective, non-interventional, single-arm study at 33 Germany dialysis centers, peritoneal dialysis patients with or without ESA treatment prior to study entry received once-monthly treatment with C.E.R.A. Hb stability was assessed by the proportion of patients for whom all measured Hb values during months 6-8 (the evaluation phase) were within the range 11-12, 11-13, 10-12 or 11-12.5 g/dL.Results220 patients received at least one dose of C.E.R.A. During the evaluation phase, 185 patients provided ≥1 Hb measurement (efficacy population) and 162 patients provided ≥2 Hb measurements (the modified efficacy population). The mean (SD) time between C.E.R.A. doses was 28.2 (7.2) days and mean (SD) C.E.R.A. dose was 109 (57) μg per application. Mean (SD) Hb level was 11.1 (1.4) g/dL at baseline and 11.5 (1.3) g/dL at the end of the study (modified efficacy population). The primary efficacy variable, all measured Hb values in the range 11-12 g/dL, was 18.4 % (34/185) and 14.8 % (24/162) in the efficacy and modified efficacy populations, respectively. The mean (SD) maximum intra-individual fluctuation in Hb level was 0.56 (0.50) g/dL in the efficacy population and 0.58 (0.49) g/dL in the modified efficacy population, with maximum intra-individual fluctuation ≤1 g/dL in 85.4 % (158/185) and 83.3 % (135/162) of patients, respectively. No adverse drug reactions were reported during the study.ConclusionIn this large population of maintenance peritoneal dialysis patients, once-monthly administration of C.E.R.A. achieved a high degree of Hb stability and was well-tolerated.

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