Effects of rhEPO-Fc on chronic renal anemia in Chinese patients undergoing maintenance hemodialysis: a multicenter, randomized, open-label, and phase 3 study

Recombinant human erythropoietin (rhEPO) fused with human immunoglobulin G (IgG) Fc fragment (rhEPO-Fc) is a novel erythropoiesis-stimulating agent designed to extend plasma half-life and enhance biological activity. However, data on the efficacy and safety of rhEPO-Fc in hemodialysis patients with chronic kidney disease (CKD)-related anemia remain limited. This phase 3 trial enrolled patients from 45 Chinese hospitals. Participants were randomized (2:1) to receive either rhEPO-Fc or rhEPO (Chinese hamster ovary cell-derived) for 28 weeks. The rhEPO-Fc responders were eligible for a 24-week extension period. The primary endpoint was the least square mean (LSM) change in hemoglobin (Hb) levels from baseline between weeks 21 and 28. Among 356 rhEPO-Fc and 178 rhEPO recipients, patients receiving rhEPO-Fc demonstrated non-inferiority Hb maintenance compared with rhEPO. The inter-group LSM differences in the full analysis set and per-protocol set were 3.96 g/L (95% CI: 3.02-4.89; <i>p</i> < 0.001) and 2.27 g/L (95% CI: 0.60-3.95; <i>p</i> = 0.008), respectively. Adverse drug reaction rates were comparable (rhEPO-Fc: 39.2% vs. rhEPO: 40.2%). Dose adjustments due to treatment-emergent adverse events were significantly lower with rhEPO-Fc (0.0% vs. 2.2%; <i>p</i> < 0.05). Deaths unrelated to the study drugs occurred in two rhEPO-Fc and four rhEPO patients. These findings indicated that rhEPO-Fc effectively maintained Hb levels in patients with CKD anemia undergoing hemodialysis, showing comparable efficacy to rhEPO with reduced dosing frequency and a similar safety profile.

Authors

Institutions

Publication Details

Journal
Renal Failure
Published
2025-12-31
DOI
https://doi.org/10.1080/0886022x.2025.2597648
Primary Topic
Erythropoietin and Anemia Treatment
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Effects of rhEPO-Fc on chronic renal anemia in Chinese patients undergoing maintenance hemodialysis: a multicenter, randomized, open-label, and phase 3 study

Aicheng Yang, P. Zhang, Fei Xiong, Yongjun Shi et al.
Renal Failure
Erythropoietin and Anemia Treatment
article

Effects of rhEPO-Fc on chronic renal anemia in Chinese patients undergoing maintenance hemodialysis: a multicenter, randomized, open-label, and phase 3 study

Aicheng Yang, P. Zhang, Fei Xiong, Yongjun Shi, Yean Hee Yu, Xinlu Gao, Jihong Ou, Y. LI, A. Q. Zhang, Yuan Qin, Xiuxian Wan, Ke Xu, Qingfeng Peng, L. Zuo, R Li, Jiaqing Peng, Jianing Wang, Wenli Chen, Yulan Shen, Hongli Jiang, Ning Cao, Weimin Yu, Xinrong Xiong, Bing Liu, Xiaoran Feng, Qingdong Xu, Jinsheng Xu, Pei Wang, Chun Yang, Rui Wen, Wenmei Zhang, Henglan Wu, Qingping Chen, Baoxing Wang, Junhua Shi, Gang Long, Cangsang Liu, Xiangming Yi, Wenxiu Chang, Huixiao Zheng, Liangying Gan, Xinxin Jiang, Lin Yang, Jingchun Yao, Hui Xu, Panna Liu, Qiang Zhu, Yi Wang, Xiaowen Li
article en

Abstract

Recombinant human erythropoietin (rhEPO) fused with human immunoglobulin G (IgG) Fc fragment (rhEPO-Fc) is a novel erythropoiesis-stimulating agent designed to extend plasma half-life and enhance biological activity. However, data on the efficacy and safety of rhEPO-Fc in hemodialysis patients with chronic kidney disease (CKD)-related anemia remain limited. This phase 3 trial enrolled patients from 45 Chinese hospitals. Participants were randomized (2:1) to receive either rhEPO-Fc or rhEPO (Chinese hamster ovary cell-derived) for 28 weeks. The rhEPO-Fc responders were eligible for a 24-week extension period. The primary endpoint was the least square mean (LSM) change in hemoglobin (Hb) levels from baseline between weeks 21 and 28. Among 356 rhEPO-Fc and 178 rhEPO recipients, patients receiving rhEPO-Fc demonstrated non-inferiority Hb maintenance compared with rhEPO. The inter-group LSM differences in the full analysis set and per-protocol set were 3.96 g/L (95% CI: 3.02-4.89; <i>p</i> < 0.001) and 2.27 g/L (95% CI: 0.60-3.95; <i>p</i> = 0.008), respectively. Adverse drug reaction rates were comparable (rhEPO-Fc: 39.2% vs. rhEPO: 40.2%). Dose adjustments due to treatment-emergent adverse events were significantly lower with rhEPO-Fc (0.0% vs. 2.2%; <i>p</i> < 0.05). Deaths unrelated to the study drugs occurred in two rhEPO-Fc and four rhEPO patients. These findings indicated that rhEPO-Fc effectively maintained Hb levels in patients with CKD anemia undergoing hemodialysis, showing comparable efficacy to rhEPO with reduced dosing frequency and a similar safety profile.

Renal FailureVol. 47(1)
Hebei Medical University (CN), American Petroleum Institute (US), Jiujiang University (CN), Central South University (CN), Shanxi Medical University (CN), Capital Medical University (CN), Changzhi Medical College (CN), Peking University (CN), Zhengzhou University (CN), Wuhan City Chinese Medicine Hospital (CN), Third Hospital of Hebei Medical University (CN), People 's Hospital of Jilin Province (CN), Xuan Wu Hospital of the Capital Medical University (CN), Lianyungang Oriental Hospital (CN), Shunyi Hospital of Beijing Traditional Chinese Medicine Hospital (CN), Shanghai University of Traditional Chinese Medicine (CN), Jiujiang First People's Hospital (CN), Second Hospital of Hebei Medical University (CN), Changsha Central Hospital (CN), Hebei General Hospital (CN), The First Hospital of Changsha (CN), Wuhan No.1 Hospital (CN), Fourth Hospital of Changsha (CN), Second Affiliated Hospital of Zhengzhou University (CN), Tianjin People's Hospital (CN), Xingtai People's Hospital (CN), Jiangmen Wuyi Traditional Chinese Medicine Hospital (CN), Zoucheng People's Hospital (CN), Zhejiang Hospital (CN), Tianjin Fourth Central Hospital (CN), First Affiliated Hospital of Xi'an Jiaotong University (CN), Jiangxi Pingxiang People's Hospital (CN), Peking University People's Hospital (CN), Tianjin Central Hospital of Gynecology Obstetrics (CN), Buchang Pharma (China) (CN), Yueyang Second People's Hospital (CN), Zhejiang Provincial People's Hospital (CN), Second Affiliated Hospital of Xi'an Jiaotong University (CN), Yueyang Hospital (CN), Zhuzhou Central Hospital (CN), Wuhan Third Hospital (CN), Huizhou Central People's Hospital (CN), First Hospital of Jiaxing (CN), First Affiliated Hospital of University of South China (CN), Central Hospital of Wuhan (CN), Third Affiliated Hospital of Zhengzhou University (CN), Affiliated Hospital of Guilin Medical College (CN), Jiangmen Central Hospital (CN), Jingzhou Central Hospital (CN), Yichang Central People's Hospital (CN), Xinxiang Central Hospital (CN), First Affiliated Hospital of Zhengzhou University (CN), Shanxi Academy of Medical Sciences (CN), Affiliated Hospital of Shandong University of Traditional Chinese Medicine (CN), Xiangya Hospital Central South University (CN), Shanxi Provincial People’s Hospital (CN), Command Hospital (IN), First Affiliated Hospital of Jinan University (CN), Huanggang Central Hospital (CN), University of South China (CN)
Good health and well-being
Openalex Percentile: Top 23%
Erythropoietin and Anemia Treatment
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.