Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis

This study is a prospective, multicenter, parallel-controlled, open-label clinical trial, planned to be conducted across multiple research centers in various provinces and cities in China. It will enroll 240 dialysis-dependent chronic kidney disease (DD-CKD) patients with anemia who have been receiving rHuEPO treatment for at least 4 weeks, with hemoglobin (Hb) levels of ≥70 g/L and \<110 g/L. After enrollment, participants will be randomly assigned in a 1:1:1 ratio to the experimental group, control group, and exploratory group. The study will involve a 24-week treatment and observation period, divided into three phases: a screening period (Day -28 to Day -1), a treatment period (Week 0 to Week 16), and an extension period (Week 17 to Week 24). The primary objective is to assess the impact of the three treatment regimens on the hemoglobin levels of patients with DD-CKD anemia.

NCT Number	NCT07045155
Lead Sponsor	Chinese PLA General Hospital Collaborators: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions	Dialysis; Complications, Chronic Kidney Disease 5D, Renal Anemia of Chronic Kidney Disease, Renal Anaemia, Renal Anemia, Chronic
Enrollment	240 participants
Start Date	2025-08-01
Primary Completion	2027-12-30 (estimated)
Study Completion	2028-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-12