Study of Pegmolesatide Alone or with Roxadustat vs rHuEPO for Treating Anemia in Adults on Long-Term Dialysis A 24-Week Multicenter, Open-Label Clinical Trial in China

What this Trial Is About

Researchers are evaluating treatments for anemia in patients with dialysis-dependent chronic kidney disease DD-CKD who have been receiving recombinant human erythropoietin rHuEPO but have hemoglobin levels below target. The study is a prospective, multicenter, parallel-controlled, open-label trial conducted in several research centers across China. It aims to assess the effects of three treatment regimens on hemoglobin levels over 24 weeks among 240 patients aged 18 to 80 years. Participants will be randomly assigned to one of three groups the experimental group receiving Pegmolesatide alone for 24 weeks the control group treated with rHuEPO for 16 weeks followed by Pegmolesatide for 8 weeks and an exploratory group receiving a combination of Pegmolesatide and roxadustat for 24 weeks. The study includes a screening phase Day -28 to Day -1, a treatment period Week 0 to Week 16, and an extension phase Week 17 to Week 24. Throughout the study, researchers will monitor hemoglobin levels and other blood parameters at regular intervals to evaluate treatment effects. Safety and dosage adjustments will be tracked. The primary outcome is the change in mean hemoglobin from baseline at weeks 12 to 16. Secondary measures include proportions of participants reaching specific hemoglobin ranges, time to target hemoglobin, red blood cell counts, and rescue therapy use. The total participation duration is about 24 weeks, including screening and follow-up.

Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis