Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis

Launched by CHINESE PLA GENERAL HOSPITAL · Jun 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Pegmolesatide for anemia (low red blood cell levels) in people who have chronic kidney disease and are on long-term dialysis. Anemia is common in kidney disease and can make patients feel very tired and weak. The study aims to see how well Pegmolesatide works to improve hemoglobin levels, which is a measure of red blood cells, compared to other treatments.

The trial plans to include about 240 adults, aged 18 to 80, who have been on dialysis for at least three months and have anemia despite receiving a common treatment called rHuEPO. Participants will be randomly assigned to one of three groups and followed for 24 weeks. During this time, they will have regular check-ups and blood tests to monitor their hemoglobin levels and overall health. People interested in joining should meet specific health criteria, such as stable anemia levels and no recent serious heart problems or infections. Pregnant women and those with certain medical conditions will not be eligible. This study is not yet recruiting, but it offers an opportunity for patients to try a potentially helpful new treatment under close medical supervision.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged ≥18 years and ≤80 years, with no restrictions on gender.
• • 2. Body weight ≥40 kg and body mass index (BMI) ≥18 kg/m².
• • 3. Diagnosed with chronic kidney disease (CKD) stage 5 for ≥12 months, and has been on hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment.
• • 4. Has been receiving rHuEPO treatment for at least 4 weeks before randomization, with an average weekly dose of \>6000 IU over the past 4 weeks (calculated as: total rHuEPO dose over the past 4 weeks/4), and the interval between the last dose and randomization is no less than 5 half-lives of rHuEPO (half-life of recombinant human erythropoietin-α: 19 hours for subcutaneous injection, 7 hours for intravenous injection).
• • 5. During the screening period, the most recent two laboratory hemoglobin (Hb) values (with at least 6 days apart) are ≥70 g/L and \<110 g/L, and the absolute difference between the two Hb values is ≤10 g/L.
• • 6. For hemodialysis patients, serum ferritin level is ≥200 μg/L; for peritoneal dialysis patients, serum ferritin level is ≥100 μg/L. The investigator determines that the patient will not require kidney transplantation as an alternative treatment throughout the trial.
• • 7. Understands the study procedures and voluntarily provides written informed consent (ICF).
• Exclusion Criteria:
• • 1. Known to have active malignancy, autoimmune diseases, hematologic disorders (including congenital and acquired anemias such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndromes, hemolytic anemia, and coagulation disorders), or other causes of anemia (such as gastrointestinal bleeding or hookworm disease).
• • 2. History of stroke, transient ischemic attack, myocardial infarction, thromboembolic events (deep vein thrombosis), pulmonary embolism, or other severe cardiopulmonary diseases within the past 6 months.
• • 3. Use of immunosuppressive agents or corticosteroids orally or intravenously, or other medications that may affect the treatment of renal anemia within 12 weeks before randomization.
• • 4. Receipt of red blood cell or whole blood transfusion within 12 weeks before the trial.
• • 5. History of significant infection within 4 weeks before randomization as determined by the investigator.
• • 6. Confirmed blood pressure measurements at rest and in a conscious state using standard measurement methods, with at least three non-consecutive day readings reaching or exceeding systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg within 4 weeks before enrollment, or changes in antihypertensive medication treatment. The primary basis for judgment is clinic-measured blood pressure values, but "white coat hypertension" should be excluded.
• • 7. Known allergy to iron agents or polyethylene glycol.
• • 8. Pregnant or breastfeeding women, women of childbearing age with a positive blood β-HCG test result before the trial, or those planning to become pregnant during the study period.
• • 9. Scheduled for elective surgery during the trial period.
• • 10. Presence of any other factors that the investigator deems unsuitable for participation in this trial.