Randomized Trial of Pegmolesatide for the Treatment of Anemia in Patients With Nondialysis CKD.

ABSTRACT:

Introduction

Pegmolesatide has been recently approved for treating anemia in chronic kidney disease (CKD) patients in China. We presented the results of the pivotal study conducted in patients with nondialysis-dependent (NDD)-CKD with anemia.

Methods

This randomized, active-controlled, open-label, noninferiority phase 3 study was conducted across 38 centers in China. Eligible patients were randomly assigned to receive subcutaneous injection of pegmolesatide in the upper arm once every 4 weeks or epoetin alfa weekly or biweekly, with doses adjusted to maintain hemoglobin (Hb) level of 100 to 120 g/l. The primary outcome was the mean change in Hb level from the baseline during the efficacy evaluation period. Noninferiority of pegmolesatide to epoetin alfa was established if th

SUBMITTER: Xie J 

PROVIDER: S-EPMC11993201 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature