biostudies-literatureGan LSichuan Luzhou Buchang Biopharmaceutical Co., LtdNCI NIH HHSSichuan Luzhou Buchang Biopharmaceutical Co., Ltd.2597648https://www.ebi.ac.uk/biostudies/studies/S-EPMC12777750biostudies-literatureUnknown47(1)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 receiRenal failureEffects of rhEPO-Fc on chronic renal anemia in Chinese patients undergoing maintenance hemodialysis: a multicenter, randomized, open-label, and phase 3 study.PMC12777750N02 PC025001Wang BWen RWan XZuo LWang JXiong XZhang PWu HShi YWang POu JChen WShen YWang YZhang AXu KYao JChen QYang LFeng XXu QLi RYang AXu HYang CXu JLi XLi YGao XXiong FYi XCao NLong GJiang HLiu PQin YZheng HJiang XYu WYu YChang WZhang WGan LPeng QLiu BLiu CShi JZhu QPeng JfalseEffects of rhEPO-Fc on chronic renal anemia in Chinese patients undergoing maintenance hemodialysis: a multicenter, randomized, open-label, and phase 3 study.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 recei2025-01-01T00:00:00Z2025 Dec2026-06-06T13:12:35.327Z2026-05-30T03:11:43.91ZS-EPMC127777504148111010.1080/0886022X.2025.2597648