Study of Pegmolesatide Treatment in Adults with Anemia from Chronic Kidney Disease on Dialysis Previously Treated with Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors

What this Trial Is About

Researchers are evaluating the use of pegmolesatide, a long-acting erythropoiesis-stimulating agent ESA, in patients with renal anemia who are currently treated with hypoxia-inducible factor prolyl hydroxylase inhibitors HIF-PHIs. This trial aims to explore the safety and effectiveness of switching from HIF-PHIs to pegmolesatide, addressing the current need for longer-acting and safe medications. The study is a multi-center, prospective, open-label, randomized parallel-controlled trial enrolling 96 dialysis chronic kidney disease patients with anemia. Participants are divided into two groups based on their current weekly Roxadustat dose a low-dose cohort 210 mg and a high-dose cohort >210 mg and 360 mg. Within each cohort, patients are randomly assigned to receive pegmolesatide at different initial doses 2 mg, 4 mg, or 6 mg administered subcutaneously once every 4 weeks. The dose may be adjusted according to the drugs instructions. The treatment period lasts 12 weeks, followed by a 16-week follow-up period. During the study, researchers will monitor hemoglobin levels and other blood parameters at various intervals to assess the effects of pegmolesatide. Patients will undergo assessments including hemoglobin tests, red blood cell counts, and safety monitoring for adverse events. The primary measurement is the change in mean hemoglobin levels from baseline to 12 and 16 weeks. The total participation time for each patient is 28 weeks, including treatment and follow-up.

A Study of Pegmolesatide of in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI)