Effects of rhEPO-Fc on chronic renal anemia in Chinese patients undergoing maintenance hemodialysis: a multicenter, randomized, open-label, and phase 3 study.

ABSTRACT: Recombinant human erythropoietin (rhEPO) fused with human immunoglobulin G (IgG) Fc fragment (rhEPO-Fc) is a novel erythropoiesis-stimulating agent designed to extend plasma half-life and enhance biological activity. However, data on the efficacy and safety of rhEPO-Fc in hemodialysis patients with chronic kidney disease (CKD)-related anemia remain limited. This phase 3 trial enrolled patients from 45 Chinese hospitals. Participants were randomized (2:1) to receive either rhEPO-Fc or rhEPO (Chinese hamster ovary cell-derived) for 28 weeks. The rhEPO-Fc responders were eligible for a 24-week extension period. The primary endpoint was the least square mean (LSM) change in hemoglobin (Hb) levels from baseline between weeks 21 and 28. Among 356 rhEPO-Fc and 178 rhEPO recipients, patients recei

SUBMITTER: Gan L 

PROVIDER: S-EPMC12777750 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature