{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T06:23:57Z","timestamp":1787293437162,"version":"build-2736575974"},"reference-count":24,"publisher":"The Korean Society of Nephrology","issue":"5","license":[{"start":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T00:00:00Z","timestamp":1783468800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003725","name":"National Research Foundation of Korea","doi-asserted-by":"publisher","award":["2018M3A9E802151"],"award-info":[{"award-number":["2018M3A9E802151"]}],"id":[{"id":"10.13039\/501100003725","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003710","name":"Korea Health Industry Development Institute","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003710","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003625","name":"Ministry of Health and Welfare","doi-asserted-by":"publisher","award":["HI14C1038"],"award-info":[{"award-number":["HI14C1038"]}],"id":[{"id":"10.13039\/501100003625","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["krcp-ksn.org"],"crossmark-restriction":true},"short-container-title":["Kidney Res Clin Pract"],"published-print":{"date-parts":[[2026,9,1]]},"abstract":"<jats:p>Background: Efepoetin alfa (GC1113, GX-E2) is a long-acting recombinant human erythropoietin fused to a hybrid fragment crystallizable (hyFc) that prolongs systemic exposure via neonatal Fc receptor-mediated recycling. This active-controlled phase 2 trial evaluated efepoetin alfa and informed phase 3 starting dose selection for chronic kidney disease-related anemia in dialysis patients. Methods: In this multicenter, open-label, active-controlled trial, adults on hemodialysis (HD) or peritoneal dialysis (PD) with hemoglobin (Hb) levels &lt;10 g\/dL were randomized after erythropoiesis-stimulating agent discontinuation. Over 12 weeks, HD patients received intravenous efepoetin alfa (5 or 8 \u00b5g\/kg once weekly [Q1W], 8 \u00b5g\/kg every 2 weeks [Q2W]) or darbepoetin alfa (30 \u00b5g Q1W). PD patients received subcutaneous efepoetin alfa (5 or 8 \u00b5g\/kg Q2W) or methoxy polyethylene glycol-epoetin beta (0.6 \u00b5g\/kg Q2W). The primary endpoint was the mean Hb change from baseline after 12 weeks of treatment, and an exploratory dose-conversion ratio (DCR) analysis was performed in the PD cohort to inform phase 3 dosing.Results: Efepoetin alfa showed dose-dependent Hb increases. In the HD cohort, mean Hb increases were 3.19 g\/dL for efepoetin alfa 5 and 8 \u00b5g\/kg Q1W and 2.52 g\/dL for darbepoetin alfa. In the PD cohort, mean Hb increases were 2.69 g\/dL and 3.48 g\/dL for efepoetin alfa 5 and 8 \u00b5g\/kg Q2W, respectively, and 2.01 g\/dL for the control group. Exploratory DCR analysis supported 4 \u00b5g\/kg Q2W efepoetin alfa as the phase 3 starting dose.Conclusion: Efepoetin alfa demonstrated dose-dependent erythropoietic efficacy and an acceptable safety profile in dialysis patients, supporting dose-range characterization and phase 3 starting dose selection.<\/jats:p>","DOI":"10.23876\/j.krcp.26.080","type":"journal-article","created":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T07:03:51Z","timestamp":1783494231000},"page":"778-791","update-policy":"https:\/\/doi.org\/10.23876\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy, safety, and dose selection of efepoetin alfa in anemic patients on maintenance dialysis: a phase 2, randomized, multicenter, active-controlled trial"],"prefix":"10.23876","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5604-1296","authenticated-orcid":true,"given":"Eun Jeong","family":"Ko","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-0418-8909","authenticated-orcid":true,"given":"Mi-Sun","family":"Byun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9796-636X","authenticated-orcid":true,"given":"Chul Woo","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7866-0955","authenticated-orcid":true,"given":"Sug Kyun","family":"Shin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8897-6598","authenticated-orcid":true,"given":"Hyung Wook","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0743-5579","authenticated-orcid":true,"given":"Byung Chul","family":"Shin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7642-2849","authenticated-orcid":true,"given":"Seok Joon","family":"Shin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1550-0812","authenticated-orcid":true,"given":"Hyeong Cheon","family":"Park","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3527-9879","authenticated-orcid":true,"given":"Young Sun","family":"Kang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9915-6221","authenticated-orcid":true,"given":"Sang-Ho","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9849-8091","authenticated-orcid":true,"given":"Ho Cheol","family":"Song","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3382-528X","authenticated-orcid":true,"given":"Su Hyun","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8872-8236","authenticated-orcid":true,"given":"Ki Young","family":"Na","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6695-7062","authenticated-orcid":true,"given":"Young-Il","family":"Jo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1068-1455","authenticated-orcid":true,"given":"Won","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6006-0051","authenticated-orcid":true,"given":"Eun Young","family":"Seong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1344-3455","authenticated-orcid":true,"given":"Yong-Lim","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-2817-3672","authenticated-orcid":true,"given":"Hyunjoo","family":"Ryu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-1832-9499","authenticated-orcid":true,"given":"Heewon","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-6778-8334","authenticated-orcid":true,"given":"Yoon-Jeong","family":"Choi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0048-5717","authenticated-orcid":true,"given":"Byung Ha","family":"Chung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"9960","reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1155\/2020\/7692376"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1161\/circulationaha.120.050686"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.3390\/biomedicines12061191"},{"key":"ref4","first-page":"279","volume-title":"KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease","year":"2012"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2015.10.002"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1093\/ndtplus\/sfq164"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1093\/ckj\/sfaa054"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.3390\/jcm14144863"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1093\/ndtplus\/sfn175"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200868080-00009"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfaa118"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcrp.2023.200220"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-024-03015-4"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1681\/asn.2007070728"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1007\/s12272-012-0500-5"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1038\/nri2155"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0024574"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-014-0183-4"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2014.114"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.5414\/cn109031"},{"key":"ref21","first-page":"157","volume-title":"Hemoglobin and hematocrit rise in end-stage renal disease (ESRD) with PDpoetin: results of a phase III, multicenter clinical trial","author":"Afshar","year":"2008"},{"key":"ref22","doi-asserted-by":"publisher","DOI":"10.2215\/cjn.10831210"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-8-8"},{"key":"ref24","first-page":"594","volume-title":"Dose-conversion ratio for epoetin alfa and darbepoetin alfa in chemotherapy patients with anemia and cancer","author":"Gosselin","year":"2006"}],"container-title":["Kidney Research and Clinical Practice"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/krcp-ksn.org\/upload\/pdf\/j-krcp-26-080.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/krcp-ksn.org\/journal\/view.php?doi=10.23876\/j.krcp.26.080","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/krcp-ksn.org\/upload\/pdf\/j-krcp-26-080.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T05:29:42Z","timestamp":1787290182000},"score":1,"resource":{"primary":{"URL":"http:\/\/krcp-ksn.org\/journal\/view.php?doi=10.23876\/j.krcp.26.080"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,1]]},"references-count":24,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,9]]}},"URL":"https:\/\/doi.org\/10.23876\/j.krcp.26.080","relation":{},"ISSN":["2211-9140"],"issn-type":[{"value":"2211-9140","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,1]]},"assertion":[{"value":"2026-03-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-10","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-08","order":2,"name":"published","label":"Published online","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-01","order":3,"name":"published","label":"Print publication","group":{"name":"publication_history","label":"Publication History"}}]}}