Abstract: TH-PO890
Recombinant Human Erythropoietin (rhEPO)-Fc for Renal Anaemia in Chinese Patients on Haemodialysis: A Multicentre, Randomised, Open-Label, Phase 3 Study
Session Information
- Anemia and Iron Metabolism
October 24, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Gan, Liangying, Peking University People's Hospital, Beijing, China
- Tong, Ling, Sichuan Luzhou Buchang BIO-Pharmaceutical Co.,Ltd., Beijing, Other, China
- Yang, Chun, Sichuan Luzhou Buchang BIO-Pharmaceutical Co.,Ltd., Beijing, Other, China
- Zuo, Li, Peking University People's Hospital, Beijing, China
Group or Team Name
- Fc-Acts Study Group.
Background
Recombinant human erythropoietin (rhEPO) Fc fusion protein (rhEPO-Fc) has been developed to prolong the plasma half-life and improve the biological activity of EPO. The efficacy and safety characteristics of rhEPO-Fc have not been investigated in renal anaemia patients.
Methods
This was a multicentre, randomised, open, positive drug controlled, phase 3 trial conducted at 45 hospitals in China (NCT05359068). After a 6-week screening period, eligible patients were randomised (2:1) to receive rhEPO-Fc initiated at 18 μg/kg once a week or rhEPO initiated at 1500 IU two to three times a week or 3000 IU twice a week for 28 weeks. Eligible patients were enrolled to the consecutive 24-week extended treatment period. The primary outcome was the change in mean haemoglobin (Hb) from baseline between week 21 and week 28. Efficacy was analysed in full analysis set (FAS) and per protocol set (PPS). Safety was assessed in all patients who received at least one dose of the investigational drugs.
Results
Between 31 May 2021 and 27 June 2023, 356 patients received rhEPO-Fc and 178 received rhEPO injection. The rhEPO-Fc treatment group resulted in a significantly greater least-square mean (LSM) of the mean Hb changes between week 21 and week 28 from baseline in the FAS and PPS populations: inter-group LSM difference of 3.96 (95% CI 3.02 to 4.89; P<0.001) and 2.27 (0.60, 3.95; P=0.008), respectively. The incidence of adverse drug reaction (ADR) in the rhEPO-Fc group was slightly lower compared with the rhEPO group (39.2% vs 40.2%). The percentage of patients with dose adjustment due to treatment emergent adverse events (TEAEs) in the rhEPO-Fc group was statistically significantly lower compared with that of the rhEPO group (0.0% vs 2.2%; P<0.05). Two patients in the rhEPO-Fc group and 4 patients in the rhEPO group died due to TEAEs that were considered not related to the investigational drugs.
Conclusion
The efficacy of rhEPO-Fc was not inferior to that of rhEPO in maintaining Hb in Chinese hemodialysis patients with anaemia and was generally well tolerated.
Funding
- Commercial Support – Sichuan Luzhou Buchang BIO-Pharmaceutical Co.,Ltd.