ArticleKidney research and clinical practice2026
Efficacy, safety, and dose selection of efepoetin alfa in anemic patients on maintenance dialysis: a phase 2, randomized, multicenter, active-controlled trial.
Article in Kidney research and clinical practice, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundEfepoetin alfa (GC1113, GX-E2) is a long-acting recombinant human erythropoietin fused to a hybrid fragment crystallizable (hyFc) that prolongs systemic exposure via neonatal Fc receptor-mediated recycling. This active-controlled phase 2 trial evaluated efepoetin alfa and informed phase 3 starting dose selection for chronic kidney disease-related anemia in dialysis patients.
methodsIn this multicenter, open-label, active-controlled trial, adults on hemodialysis (HD) or peritoneal dialysis (PD) with hemoglobin (Hb) levels <10 g/dL were randomized after erythropoiesis-stimulating agent discontinuation. Over 12 weeks, HD patients received intravenous efepoetin alfa (5 or 8 µg/kg once weekly [Q1W], 8 µg/kg every 2 weeks [Q2W]) or darbepoetin alfa (30 µg Q1W). PD patients received subcutaneous efepoetin alfa (5 or 8 µg/kg Q2W) or methoxy polyethylene glycol-epoetin beta (0.6 µg/kg Q2W). The primary endpoint was the mean Hb change from baseline after 12 weeks of treatment, and an exploratory dose-conversion ratio (DCR) analysis was performed in the PD cohort to inform phase 3 dosing.
resultsEfepoetin alfa showed dose-dependent Hb increases. In the HD cohort, mean Hb increases were 3.19 g/dL for efepoetin alfa 5 and 8 µg/kg Q1W and 2.52 g/dL for darbepoetin alfa. In the PD cohort, mean Hb increases were 2.69 g/dL and 3.48 g/dL for efepoetin alfa 5 and 8 µg/kg Q2W, respectively, and 2.01 g/dL for the control group. Exploratory DCR analysis supported 4 µg/kg Q2W efepoetin alfa as the phase 3 starting dose.
conclusionEfepoetin alfa demonstrated dose-dependent erythropoietic efficacy and an acceptable safety profile in dialysis patients, supporting dose-range characterization and phase 3 starting dose selection.
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