Evidence map›Paper›PMID 40369895›Full record

Trial reportNephrology (Carlton, Vic.)2025

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.

Simon D Roger, Chew Ming Wong, Phisitt Vejakama, Kuspudji Dwitanto Rahardjo, Bang-Gee Hsu, Chang Meng Lee, I-Wen Wu, Chin-Chan Lee, Tunggul Diapari Situmorang, Pajaree Krisanapan and 36 more

Abstract readMulticenter StudyClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nephrology (Carlton, Vic.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

46 authors.

Simon D RogerRenal Research, Gosford, New South Wales, Australia.ORCID https://orcid.org/0000-0002-8299-2650
Chew Ming WongUniversity Malaya Medical Centre, Petaling Jaya, Malaysia.
Phisitt VejakamaSunpasitthiprasong Hospital, Ubon Ratchathani, Thailand.
Kuspudji Dwitanto RahardjoIslam Cempaka Putih Hospital, Jakarta, Indonesia.
Bang-Gee HsuHualien Tzu Chi Hospital, Hualien City, Taiwan.
Chang Meng LeeHospital Seri Manjung, Seri Manjung, Malaysia.
I-Wen WuKeelung Chang Gung Memorial Hospital, Keelung City, Taiwan.ORCID https://orcid.org/0000-0001-8535-3582
Chin-Chan LeeKeelung Chang Gung Memorial Hospital, Keelung City, Taiwan.
Tunggul Diapari SitumorangPGI Cikini Hospital, Jakarta, Indonesia.
Pajaree KrisanapanThammasat University Hospital, Pathum Thani, Thailand.
Sadanah Aqashiah MazlanHospital Kajang, Kajang, Malaysia.
Yu-Sen PengFar Eastern Memorial Hospital, New Taipei City, Taiwan.
Johanes SarwonoFatmawati Central General Hospital, Jakarta, Indonesia.
Norman De AsisNorzel Medical and Diagnostics Clinic, Cebu City, Philippines.
Domingo SolimenBaguio General Hospital Medical Centre, Baguio, Philippines.
JonnyGatot Subroto Central Army Hospital, Jakarta, Indonesia.
Pornpen SangthawanSongklanagarind Hospital, Songkhla, Thailand.
Jin-Bor ChenKaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan.
Chia-Liang WangKuang Tien General Hospital, Taichung City, Taiwan.
Sungjin ChungYeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.
Agnes Jeans VillaflorM3 Dialysis Centre, Bacolod, Philippines.
Chul Woo YangSeoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.
Wei-Chih KanChi Mei Medical Center, Tainan City, Taiwan.
Yu YangChanghua Christian Hospital, Changhua City, Taiwan.
Jenny Rubio-BicolDe La Salle Medical and Health Sciences Institute, Cavite, Philippines.
Lee Yee YanHospital Raja Permaisuri Bainun, Ipoh, Malaysia.
Sang Ho LeeKyung Hee University Hospital at Gangdong, Seoul, South Korea.
Yi-Wen ChiuKaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan.
Cheng-Hsu ChenTaichung Veterans General Hospital, Taichung City, Taiwan.
Ki Young NaSeoul National University Bundang Hospital, Seoul, South Korea.
Wan Hasnul Halimi Wan HassahHospital Raja Perempuan Zainab 2, Kota Bharu, Malaysia.
Young Sun KangKorea University Hospital Ansan, Ansan-si, South Korea.
Bum-Soon ChoiEunpyeong St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.
Grace AquitaniaDavao Doctors Hospital, Davao, Philippines.
Ki Ryang NaChungnam National University Hospital, Daejeon, South Korea.
Mai-Szu WuTaipei Medical University-Shuang Ho Hospital, Taipei City, Taiwan.
Mohd Kamil AhmadHospital Tengku Ampuan Afzan, Kuantan, Malaysia.
Rey IsidtoWest Visayas State University Hospital, Iloilo City, Philippines.ORCID https://orcid.org/0000-0002-4863-9079
Vincent WuNational Taiwan University Hospital, Taipei City, Taiwan.
Goh Bak LeongHospital Serdang, Serdang, Malaysia.
Junne-Ming SungNational Cheng Kung University Hospital, Tainan City, Taiwan.
Kajohnsak NoppakunMaharaj Nakorn Chiang Mai, Chiang Mai, Thailand.ORCID https://orcid.org/0000-0002-5783-8766
Kang-Ju ChouKaohsiung Veterans General Hospital, Kaohsiung City, Taiwan.
Mohamad Zaimi Abdul WahabHospital Kuala Lumpur, Kuala Lumpur, Malaysia.ORCID https://orcid.org/0000-0002-6628-3651
Seok Joon ShinIncheon St. Mary's Hospital, The Catholic University of Korea, Incheon, South Korea.ORCID https://orcid.org/0000-0001-7642-2849
Pringgodigdo NugrohoDr. Cipto Mangunkusumo National Central Public Hospital, Jakarta, Indonesia.

Funding

Kalbe Genexine Biologics
6 · The paper itself

Abstract

aimEfepoetin 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.

methodsA 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.

resultsIn the efepoetin alfa Q2W (every 2 weeks) group, the response rate was 75.6%; while in the methoxy polyethylene glycol-epoetin beta Q2W group, the response rate was 69.3%. The difference in the response rate was 6.3% with 95% CI (confidence interval) -3.1% to 15.5%. The lower limit of the 95% CI was above the prespecified non-inferiority margin of -9.0%. Adverse event rates were comparable between the treatment groups.

conclusionEfepoetin alfa demonstrated non-inferiority to methoxy polyethylene glycol-epoetin 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-epoetin beta.

Indexed as

AnemiaErythropoietinHematinicsPolyethylene GlycolsRecombinant Fusion ProteinsRenal Insufficiency, ChronicAdultAgedBiomarkersFemaleHemoglobinsHumansInjections, SubcutaneousMaleMiddle AgedRecombinant ProteinsBiomarkersepoetin betaErythropoietinHematinicsHemoglobinsmonomethoxypolyethylene glycolPolyethylene GlycolsRecombinant Fusion ProteinsRecombinant Proteinsanaemiachronic kidney diseaseefepoetin alfalong‐acting erythropoiesis‐stimulating agent

Identifiers

PMID40369895
PMCPMC12079003

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.