Pegmolesatide for Anemia Treatment：Investigation Upgrade Therapy in rhuEPO Patients Undergoing Dialysis: A Prospective, Multicenter, Parallel-Group, Controlled, Open-Label Study（PANGU-stepup）
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.
• Aged ≥18 years and ≤80 years, with no restrictions on gender.
• Body weight ≥40 kg and body mass index (BMI) ≥18 kg/m².
• Subjects who have received hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment;
• Subjects who have been receiving erythropoiesis-stimulating agents (ESAs) for ≥4 weeks prior to randomization, with an average weekly dose \>6000 IU in the last 4 weeks (equivalent dose converted to short-acting EPO \>6000 IU, calculated as the total amount of short-acting EPO used in the last 4 weeks divided by 4);
• The most recent Hb value during the screening period and the average Hb value between screening and baseline visits must be ≥70 to \<110 g/L;
• Hemodialysis patients with serum ferritin levels ≥200 μg/L; peritoneal dialysis patients with serum ferritin levels ≥100 μg/L, and the investigator determines that renal transplant is not required during the trial;
• Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF).