Abstract: TH-PO702
Pegmolesatide for the Treatment of Anemia in NDD-CKD Patients: A Multicenter Randomized Active-Controlled Phase 3 Trial
Session Information
- Anemia and Iron Metabolism
November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Lin, Ting, Guangdong Gerneral Hospital, Guangzhou, China
- Yang, Aicheng, Jiangmen Wuyi Traditional Chinese Medicine Hospital, Jiangmen, China
- Qiu, Hongyu, Sichuan University West China Hospital, Chengdu, Sichuan, China
- Peng, Xiaomei, The people hospital of Guangxi Zhuang Autonomous Region, Nanning, China
- Lu, Wanhong, The First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an, China
- Tang, Shuifu, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China
- Chen, Qinkai, The First Affiliated Hospital of Nanchang University, Nanchang, China
- Huang, Xiangyang, Liu Zhou worker's hospital, Liuzhou, China
- Zhong, Aimin, Jiangxi Provincial People's Hospital, Nanchang, China
- Yu, Xueqing, Guangdong Gerneral Hospital, Guangzhou, China
Background
Pegmolesatide, a synthetic peptide-based erythropoiesis-stimulating agent (ESA), is a potential long-acting drug for the treatment of anemia in chronic kidney disease (CKD) patients. Efficacy and safety of Pegmolesatide would be evaluated in non-dialysis-dependent(NDD)-CKD populations.
Methods
A multicenter, randomized, open-label, active-controlled, non-inferiority phase 3 trial was conducted at 38 centers in China. Eligible NDD-CKD patients who were not receiving ESAs were randomly assigned (2:1) to receive Pegmolesatide once in every four weeks (at a starting dose of 0.04 mg/kg) or Epoetin alfa weekly or biweekly (at a starting dose of 6000 IU per week). During the 52-week study, dosages were adjusted as needed to achieve and maintain hemoglobin(Hb) level between 10.0 and 12.0 g/dL. The primary endpoint was the change in Hb level from baseline to the evaluation period (week 17 through 24). Non-inferiority would be established if the lower boundary of 95% confidence interval for the Hb change difference (Pegmolesatide-Epoetin alfa) was greater than -1.0 g/dL. Safety profile was assessed. Cardiovascular safety was evaluated on the basis of composite safety endpoints (death, stroke and myocardial infarction).
Results
A total of 175 patients were randomized, and 135 patients (86 in the Pegmolesatide group and 49 in the Epoetin alfa group) completed a 24-week treatment. The median duration of exposure was 36.63 and 37.95 weeks respectively in the Pegmolesatide and Epoetin alfa group. The demographics and baseline characteristics were balanced between two groups. The non-inferiority was reached in Full-Analysis Set and Per-Protocol Set. Of the 173 patients who received at least one dose, the incidences of adverse events (AEs) and serious AEs (SAEs) were similar in both groups, and hypertension was the most common AE related to the study drug (5.2% in the Pegmolesatide group and 13.8% in the Epoetin alfa group). The composite safety endpoints were occurred in 1 patient (0.9%) who received Pegmolesatide and in 2 patients (3.4%) who received Epoetin alfa.
Conclusion
Long-acting Pegmolesatide was similar to Epoetin alfa in efficacy and safety, which could be used for treatment of anemia in NDD-CKD patients.
Funding
- Commercial Support –