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
Journal
Nephrology
Journal Volume
30
Journal Issue
5
Start Page
Article number e70046
ISSN
1320-5358
1440-1797
Date Issued
2025-05
Author(s)
Roger, Simon D.
Wong, Chew Ming
Vejakama, Phisitt
Rahardjo, Kuspudji Dwitanto
Hsu, Bang‐Gee
Lee, Chang Meng
Wu, I-Wen
Lee, Chin-Chan
Situmorang, Tunggul Diapari
Krisanapan, Pajaree
Mazlan, Sadanah Aqashiah
Peng, Yu-Sen
Sarwono, Johanes
De Asis, Norman
Solimen, Domingo
Sangthawan, Pornpen
Chen, Jin-Bor
Wang, Chia-Liang
Chung, Sungjin
Villaflor, Agnes Jeans
Yang, Chul Woo
Kan, Wei-Chih
Yang, Yu
Rubio-Bicol, Jenny
Yan, Lee Yee
Lee, Sang Ho
Chiu, Yi-Wen
Chen, Cheng‐Hsu
Na, Ki Young
Hassah, Wan Hasnul Halimi Wan
Kang, Young Sun
Choi, Bum-Soon
Aquitania, Grace
Na, Ki Ryang
Wu, Mai-Szu
Ahmad, Mohd Kamil
Isidto, Rey
Leong, Goh Bak
Sung, Junne-Ming
Noppakun, Kajohnsak
Chou, Kang-Ju
Abdul Wahab, Mohamad Zaimi
Shin, Seok Joon
Nugroho, Pringgodigdo
Abstract
ABSTRACT
Aim
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.
Methods
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.
Results
In 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.
Conclusion
Efepoetin 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.
Subjects
anaemia
chronic kidney disease
efepoetin alfa
long‐acting erythropoiesis‐stimulating agent
Publisher
Wiley
Type
journal article