{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T18:33:41Z","timestamp":1788201221091,"version":"build-2803163510"},"reference-count":28,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:00:00Z","timestamp":1747180800000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Nephrology"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>Efepoetin alfa, a novel long\u2010acting erythropoietin (EPO)\u2010hybrid Fc fusion protein, represents a promising erythropoiesis\u2010stimulating 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\u2010epoetin beta in stage 3 or 4 CKD patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A randomised, multicentre, open\u2010label Phase 3 trial enrolled 391 CKD stage 3 or stage 4 patients. Subjects underwent a 20\u2010week correction period followed by an 8\u2010week evaluation period. Responders continued treatment for an extra 24\u2010week extension to evaluate long\u2010term safety, maintenance effectiveness, and the longer treatment interval.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the efepoetin alfa Q2W (every 2\u2009weeks) group, the response rate was 75.6%; while in the methoxy polyethylene glycol\u2010epoetin beta Q2W group, the response rate was 69.3%. The difference in the response rate was 6.3% with 95% CI (confidence interval) \u20133.1% to 15.5%. The lower limit of the 95% CI was above the prespecified non\u2010inferiority margin of \u22129.0%. Adverse event rates were comparable between the treatment groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Efepoetin alfa demonstrated non\u2010inferiority to methoxy polyethylene glycol\u2010epoetin beta in correcting anaemia and maintaining haemoglobin (Hb) levels among stage 3 and 4 CKD patients. Moreover, the safety profile of efepoetin alfa was comparable to methoxy polyethylene glycol\u2010epoetin beta.<\/jats:p><\/jats:sec>","DOI":"10.1111\/nep.70046","type":"journal-article","created":{"date-parts":[[2025,5,15]],"date-time":"2025-05-15T05:30:18Z","timestamp":1747287018000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Non\u2010Inferiority of Subcutaneous Efepoetin Alfa Compared to Methoxy Polyethylene Glycol\u2010Epoetin Beta in Stage 3 or 4 <scp>CKD<\/scp> Patients: Insights From a Phase 3 Trial"],"prefix":"10.1111","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8299-2650","authenticated-orcid":false,"given":"Simon D.","family":"Roger","sequence":"first","affiliation":[{"name":"Renal Research  Gosford New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chew Ming","family":"Wong","sequence":"additional","affiliation":[{"name":"University Malaya Medical Centre  Petaling Jaya Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phisitt","family":"Vejakama","sequence":"additional","affiliation":[{"name":"Sunpasitthiprasong Hospital  Ubon Ratchathani Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kuspudji Dwitanto","family":"Rahardjo","sequence":"additional","affiliation":[{"name":"Islam Cempaka Putih Hospital  Jakarta Indonesia"},{"name":"Islam Pondok Kopi Hospital  Jakarta Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bang\u2010Gee","family":"Hsu","sequence":"additional","affiliation":[{"name":"Hualien Tzu Chi Hospital  Hualien City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chang Meng","family":"Lee","sequence":"additional","affiliation":[{"name":"Hospital Seri Manjung  Seri Manjung Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8535-3582","authenticated-orcid":false,"given":"I\u2010Wen","family":"Wu","sequence":"additional","affiliation":[{"name":"Keelung Chang Gung Memorial Hospital  Keelung City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chin\u2010Chan","family":"Lee","sequence":"additional","affiliation":[{"name":"Keelung Chang Gung Memorial Hospital  Keelung City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tunggul Diapari","family":"Situmorang","sequence":"additional","affiliation":[{"name":"PGI Cikini Hospital  Jakarta Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pajaree","family":"Krisanapan","sequence":"additional","affiliation":[{"name":"Thammasat University Hospital  Pathum Thani Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sadanah Aqashiah","family":"Mazlan","sequence":"additional","affiliation":[{"name":"Hospital Kajang  Kajang Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu\u2010Sen","family":"Peng","sequence":"additional","affiliation":[{"name":"Far Eastern Memorial Hospital  New Taipei City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johanes","family":"Sarwono","sequence":"additional","affiliation":[{"name":"Fatmawati Central General Hospital  Jakarta Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norman","family":"De Asis","sequence":"additional","affiliation":[{"name":"Norzel Medical and Diagnostics Clinic  Cebu City Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domingo","family":"Solimen","sequence":"additional","affiliation":[{"name":"Baguio General Hospital Medical Centre  Baguio Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"family":"Jonny","sequence":"additional","affiliation":[{"name":"Gatot Subroto Central Army Hospital  Jakarta Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pornpen","family":"Sangthawan","sequence":"additional","affiliation":[{"name":"Songklanagarind Hospital  Songkhla Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin\u2010Bor","family":"Chen","sequence":"additional","affiliation":[{"name":"Kaohsiung Chang Gung Memorial Hospital  Kaohsiung City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chia\u2010Liang","family":"Wang","sequence":"additional","affiliation":[{"name":"Kuang Tien General Hospital  Taichung City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sungjin","family":"Chung","sequence":"additional","affiliation":[{"name":"Yeouido St. Mary's Hospital The Catholic University of Korea  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnes Jeans","family":"Villaflor","sequence":"additional","affiliation":[{"name":"M3 Dialysis Centre  Bacolod Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chul Woo","family":"Yang","sequence":"additional","affiliation":[{"name":"Seoul St. Mary's Hospital The Catholic University of Korea  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei\u2010Chih","family":"Kan","sequence":"additional","affiliation":[{"name":"Chi Mei Medical Center  Tainan City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Yang","sequence":"additional","affiliation":[{"name":"Changhua Christian Hospital  Changhua City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenny","family":"Rubio\u2010Bicol","sequence":"additional","affiliation":[{"name":"De La Salle Medical and Health Sciences Institute  Cavite Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lee Yee","family":"Yan","sequence":"additional","affiliation":[{"name":"Hospital Raja Permaisuri Bainun  Ipoh Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang Ho","family":"Lee","sequence":"additional","affiliation":[{"name":"Kyung Hee University Hospital at Gangdong  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi\u2010Wen","family":"Chiu","sequence":"additional","affiliation":[{"name":"Kaohsiung Medical University Chung\u2010Ho Memorial Hospital  Kaohsiung City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheng\u2010Hsu","family":"Chen","sequence":"additional","affiliation":[{"name":"Taichung Veterans General Hospital  Taichung City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ki Young","family":"Na","sequence":"additional","affiliation":[{"name":"Seoul National University Bundang Hospital  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wan Hasnul Halimi Wan","family":"Hassah","sequence":"additional","affiliation":[{"name":"Hospital Raja Perempuan Zainab 2  Kota Bharu Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Young Sun","family":"Kang","sequence":"additional","affiliation":[{"name":"Korea University Hospital Ansan  Ansan\u2010si South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bum\u2010Soon","family":"Choi","sequence":"additional","affiliation":[{"name":"Eunpyeong St. Mary's Hospital The Catholic University of Korea  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grace","family":"Aquitania","sequence":"additional","affiliation":[{"name":"Davao Doctors Hospital  Davao Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ki Ryang","family":"Na","sequence":"additional","affiliation":[{"name":"Chungnam National University Hospital  Daejeon South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mai\u2010Szu","family":"Wu","sequence":"additional","affiliation":[{"name":"Taipei Medical University\u2010Shuang Ho Hospital  Taipei City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohd Kamil","family":"Ahmad","sequence":"additional","affiliation":[{"name":"Hospital Tengku Ampuan Afzan  Kuantan Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4863-9079","authenticated-orcid":false,"given":"Rey","family":"Isidto","sequence":"additional","affiliation":[{"name":"West Visayas State University Hospital  Iloilo City Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent","family":"Wu","sequence":"additional","affiliation":[{"name":"National Taiwan University Hospital  Taipei City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Goh Bak","family":"Leong","sequence":"additional","affiliation":[{"name":"Hospital Serdang  Serdang Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junne\u2010Ming","family":"Sung","sequence":"additional","affiliation":[{"name":"National Cheng Kung University Hospital  Tainan City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5783-8766","authenticated-orcid":false,"given":"Kajohnsak","family":"Noppakun","sequence":"additional","affiliation":[{"name":"Maharaj Nakorn Chiang Mai  Chiang Mai Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kang\u2010Ju","family":"Chou","sequence":"additional","affiliation":[{"name":"Kaohsiung Veterans General Hospital  Kaohsiung City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6628-3651","authenticated-orcid":false,"given":"Mohamad Zaimi","family":"Abdul Wahab","sequence":"additional","affiliation":[{"name":"Hospital Kuala Lumpur  Kuala Lumpur Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7642-2849","authenticated-orcid":false,"given":"Seok Joon","family":"Shin","sequence":"additional","affiliation":[{"name":"Incheon St. Mary's Hospital The Catholic University of Korea  Incheon South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pringgodigdo","family":"Nugroho","sequence":"additional","affiliation":[{"name":"Dr. Cipto Mangunkusumo National Central Public Hospital  Jakarta Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,14]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0158765"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30045-3"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-020-01607-4"},{"issue":"2","key":"e_1_2_8_5_1","first-page":"303","article-title":"Prevalence of Anaemia in Adults With Chronic Kidney Disease in a Representative Sample of the United States Population: Analysis of the 1999\u20102018 National Health and Nutrition Examination Survey","volume":"16","author":"Kovesdy C. P.","year":"2022","journal-title":"Clinical Journal of the American Society of Nephrology"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ki.5000105"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2005.03.055"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12882\u2010020\u201001746\u20104"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1159\/000213166"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.3111\/13696998.2010.484307"},{"issue":"2","key":"e_1_2_8_11_1","first-page":"244","article-title":"Contemporary Outcomes of Anaemia in US Patients With Chronic Kidney Disease","volume":"15","author":"Wittbrodt E. T.","year":"2022","journal-title":"Clinical Journal of the American Society of Nephrology"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11255-013-0640-7"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3271"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm12020625"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2018101007"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ekir.2020.10.003"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2021.642296"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2012.07.014"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0024574"},{"key":"e_1_2_8_20_1","unstructured":"\u201cMircera (Methoxy Polyethylene Glycol\u2010Epoetin Beta); Sydney (AU): Roche Products Pty Limited \u201dlast modified November 23 2023 https:\/\/www.roche\u2010australia.com\/solutions\/pharma\u2010solutions\/mircera."},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1185\/030079906X148283"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1755-6686.2004.tb00328.x"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1523-1755.2005.00532.x"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfm384"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.4081\/nr.2010.e1"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2007010058"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1159\/000518071"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1159\/000518073"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ekir.2020.11.034"}],"container-title":["Nephrology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/nep.70046","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,26]],"date-time":"2025-05-26T06:22:29Z","timestamp":1748240549000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/nep.70046"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5]]},"references-count":28,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5]]}},"alternative-id":["10.1111\/nep.70046"],"URL":"https:\/\/doi.org\/10.1111\/nep.70046","archive":["Portico"],"relation":{},"ISSN":["1320-5358","1440-1797"],"issn-type":[{"value":"1320-5358","type":"print"},{"value":"1440-1797","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5]]},"assertion":[{"value":"2024-10-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-14","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70046"}}