Abstract: SA-PO1106
Dose Conversion from Roxadustat to Pegmolesatide in Dialysis-Dependent Patients with Anemia of CKD: A Multicenter Open-Label Randomized Controlled Trial Interim Analysis
Session Information
- Kidney Replacement Therapy and Care Delivery Innovations
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Ye, Zhiming, Guangdong Provincial People's Hospital, Guangzhou, China
- Li, Junhua, Huazhong University of Science and Technology Tongji Medical College Tongji Hospital, Wuhan, China
- Wang, Zhixiang, Huazhong University of Science and Technology Tongji Medical College Tongji Hospital, Wuhan, China
- Quan, Zhengli, Jingmen Central Hospital, Jingmen, China
- Yao, Li, The First Hospital of China Medical University, Shenyang, China
- Wu, Senchao, Longyan First Hospital, Longyan, China
- Hu, Zhizhen, Hansoh Pharmaceutical Group Co, Ltd, Shanghai, China
- Li, Ping, Hansoh Pharmaceutical Group Co, Ltd, Shanghai, China
- Cheng, Xue, Hansoh Pharmaceutical Group Co, Ltd, Shanghai, China
- Xu, Gang, Huazhong University of Science and Technology Tongji Medical College Tongji Hospital, Wuhan, China
- Yu, Xueqing, Guangdong Provincial People's Hospital, Guangzhou, China
Background
Pegmolesatide is a novel long-acting erythropoietin mimetic peptide for the treatment of renal anemia. Currently, no standardized dose conversion guideline is available for patients switching from hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) to pegmolesatide. This interim analysis aimed to evaluate the efficacy of different initial treatment doses of pegmolesatide in dialysis-dependent chronic kidney disease (DD-CKD) patients with anemia previously treated with roxadustat.
Methods
This ongoing trial (NCT07136792) is an exploratory study without prespecified hypothesis testing, and plans to enroll 96 DD-CKD patients with baseline hemoglobin (Hb) between 80-120 g/L. Based on the weekly roxadustat dose prior to randomization, patients were assigned to a low-dose group (≤210 mg) or a high-dose group (>210 mg and ≤360 mg). Each group was further randomized 1:1 to receive different initial treatment doses of pegmolesatide: 2 mg vs. 4 mg in the low-dose group and 4 mg vs. 6 mg in the high-dose group. Pegmolesatide was administered subcutaneously once every 4 weeks for 12 weeks, with 16 weeks of follow-up. The primary endpoint was the change in Hb level from baseline to the mean value of Week 12-16.
Results
At data cutoff, 24 patients were included in the full analysis set. Baseline characteristics were comparable: mean age was 51.6 years, percentage of males was 66.7%, 87.5% of patients were in CKD stage 5, 70.8% of patients were receiving hemodialysis, and mean baseline Hb level was 104.7±10.9 g/L. The overall change from baseline in Hb level to the mean value of Week 12-16 was 0.56±13.73 g/L. In the low-dose group, the change in Hb level was -1.64±11.25 g/L (2 mg: -7.70±7.84 g/L; 4 mg: 3.42±11.69 g/L; Least-Squares Mean [LSMEAN] difference: 11.23, 95% CI: -5.03 to 27.49, P=0.147). In the high-dose group, the change in Hb level was 2.42±15.73 g/L (4 mg: 0.31±12.41 g/L; 6 mg: 5.80±21.20 g/L; LSMEAN difference: 5.82, 95% CI: -16.85 to 28.49, P=0.576). No significant differences were observed between initial doses within each group.
Conclusion
This interim analysis suggests that conversion from roxadustat to once monthly pegmolesatide may effectively maintain Hb levels in DD-CKD patients. The dose-dependent trends support the continuation of this ongoing dose conversion study.