biostudies-literatureUnknown30(5)Roger SDKalbe Genexine Biologics<h4>Aim</h4>Efepoetin alfa, a novel long-acting erythropoietin (EPO)-hybrid Fc fusion protein, represents a promising erythropoiesis-stimulating agent (ESA) for addressing anaemia in chronic kidney disease (CKD) patients. This Phase 3 trial was to assess the efficacy and tolerability of subcutaneous efepoetin alfa in comparison to subcutaneous methoxy polyethylene glycol-epoetin beta in stage 3 or 4 CKD patients.<h4>Methods</h4>A randomised, multicentre, open-label Phase 3 trial enrolled 391 CKD stage 3 or stage 4 patients. Subjects underwent a 20-week correction period followed by an 8-week evaluation period. Responders continued treatment for an extra 24-week extension to evaluate long-term safety, maintenance effectiveness, and the longer treatment interval.<h4>Results</h4>In the efepoeNephrology (Carlton, Vic.)e70046https://www.ebi.ac.uk/biostudies/studies/S-EPMC12079003biostudies-literatureNon-Inferiority of Subcutaneous Efepoetin Alfa Compared to Methoxy Polyethylene Glycol-Epoetin Beta in Stage 3 or 4 CKD Patients: Insights From a Phase 3 Trial.PMC12079003Roger SDSung JMSangthawan PWang CLAquitania GShin SJHassah WHHWAhmad MKMazlan SAYan LYChen JBIsidto RChiu YWWong CMHsu BGYang CWKang YSWu VRubio-Bicol JChung SNa KRVejakama PPeng YSNoppakun KLee SHVillaflor AJChen CHNa KYSolimen DNugroho PWu IWSarwono JKan WCJonnyLee CMYang YDe Asis NSitumorang TDKrisanapan PChoi BSWu MSLee CCLeong GBRahardjo KDChou KJAbdul Wahab MZfalseNon-Inferiority of Subcutaneous Efepoetin Alfa Compared to Methoxy Polyethylene Glycol-Epoetin Beta in Stage 3 or 4 CKD Patients: Insights From a Phase 3 Trial.<h4>Aim</h4>Efepoetin alfa, a novel long-acting erythropoietin (EPO)-hybrid Fc fusion protein, represents a promising erythropoiesis-stimulating agent (ESA) for addressing anaemia in chronic kidney disease (CKD) patients. This Phase 3 trial was to assess the efficacy and tolerability of subcutaneous efepoetin alfa in comparison to subcutaneous methoxy polyethylene glycol-epoetin beta in stage 3 or 4 CKD patients.<h4>Methods</h4>A randomised, multicentre, open-label Phase 3 trial enrolled 391 CKD stage 3 or stage 4 patients. Subjects underwent a 20-week correction period followed by an 8-week evaluation period. Responders continued treatment for an extra 24-week extension to evaluate long-term safety, maintenance effectiveness, and the longer treatment interval.<h4>Results</h4>In the efepoe2025-01-01T00:00:00Z2025 May2026-07-15T08:28:10.645Z2026-07-01T03:12:08.727ZS-EPMC120790034036989510.1111/nep.70046