Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis

title： Pegmolesatide for anemia treatment：investigation upgrade therapy in rhuEPO patients undergoing dialysis: A Prospective, Multicenter, Parallel-Group, Controlled, Open-Label Study（PANGU-upgrade） Introduction: Anemia is a primary complication of chronic kidney disease (CKD). In recent years, there have been many effective strategies for treating anemia in CKD, including erythropoiesis-stimulating agents (ESAs), hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), and erythropoietin (EPO) mimetic peptides (EMPs) such as Pegmolesatide. This study aims to explore the efficacy and safety of switching patients with anemia of dialysis-dependent chronic kidney disease (DD-CKD), whose hemoglobin (Hb) levels have not reached the target after treatment with recombinant human erythropoietin (rHuEPO), to treatment with pegmolesatide. Methods: This study is designed as a prospective, multicenter, parallel-controlled, open-label trial. It plans to enroll 240 participants with anemia of dialysis-dependent chronic kidney disease (DD-CKD) who have been receiving recombinant human erythropoietin (rHuEPO) treatment for at least 4 weeks, with hemoglobin (Hb) levels of ≥70 g/L and \<110 g/L. Participants will be randomly assigned in a 1:1:1 ratio to the experimental group, the control group, and the exploratory group. The study will consist of a 24-week treatment and observation period, divided into three phases: the screening period (Day -28 to Day -1), the treatment period (Week 0 to Week 16), and the extension period (Week 17 to Week 24). This study plans to recruit participants from 20 large tertiary hospitals across multiple provinces and cities in China. The primary endpoint of the study is the change in mean hemoglobin (Hb) levels from baseline at weeks 12 to 16 of treatment in the three groups. The study will observe and evaluate the efficacy and safety of switching patients with anemia of dialysis-dependent chronic kidney disease (DD-CKD) who have not achieved target Hb levels after treatment with recombinant human erythropoietin (rHuEPO) to treatment with pegmolesatide alone or pegmolesatide in combination with roxadustat.