{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["30(5)"],"submitter":["Roger SD"],"funding":["Kalbe Genexine Biologics"],"pubmed_abstract":["<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 efepoe"],"journal":["Nephrology (Carlton, Vic.)"],"pagination":["e70046"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12079003"],"repository":["biostudies-literature"],"pubmed_title":["Non-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."],"pmcid":["PMC12079003"],"pubmed_authors":["Roger SD","Sung JM","Sangthawan P","Wang CL","Aquitania G","Shin SJ","Hassah WHHW","Ahmad MK","Mazlan SA","Yan LY","Chen JB","Isidto R","Chiu YW","Wong CM","Hsu BG","Yang CW","Kang YS","Wu V","Rubio-Bicol J","Chung S","Na KR","Vejakama P","Peng YS","Noppakun K","Lee SH","Villaflor AJ","Chen CH","Na KY","Solimen D","Nugroho P","Wu IW","Sarwono J","Kan WC","Jonny","Lee CM","Yang Y","De Asis N","Situmorang TD","Krisanapan P","Choi BS","Wu MS","Lee CC","Leong GB","Rahardjo KD","Chou KJ","Abdul Wahab MZ"],"additional_accession":[]},"is_claimable":false,"name":"Non-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.","description":"<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 efepoe","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 May","modification":"2026-07-15T08:28:10.645Z","creation":"2026-07-01T03:12:08.727Z"},"accession":"S-EPMC12079003","cross_references":{"pubmed":["40369895"],"doi":["10.1111/nep.70046"]}}