Switching to Pegmolesatide in non-dialysis CKD with renal anemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, open-label phase 4 trial compares two Pegmolesatide dosing strategies over 48 weeks in about 160 adults with CKD-related anemia who are on rHuEPO or a HIF-PHI. Participants are randomized 1:1 to receive either an optimized Pegmolesatide regimen or a standard regimen, with initial doses based on weight and adjustments every four weeks guided by hemoglobin levels. The primary endpoint is the change in hemoglobin from baseline at week 24, with a 24-week extension period to assess longer-term effects. The study aims to determine if Pegmolesatide can maintain or improve Hb levels while offering a non-inferiority comparison to standard strategies.

Why it matters

Who can join: the full rules

* Inclusion Criteria:

  1. Aged ≥18 years and ≤80 years, regardless of gender;
  2. Body weight ≥45 kg; Body Mass Index (BMI) ≥18.5 kg/m²;
  3. Diagnosed with chronic kidney disease (CKD) complicated by renal anemia, with an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m² before randomization (GFR estimation using the CKD-EPI formula); Undergoing continuous treatment with rHuEPO or HIF-PHI for ≥2 weeks before randomization;
  4. Hemoglobin (Hb) level measured within 7 days before randomization ≥70 g/L and \< 110 g/L;
  5. Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF)
* Exclusion Criteria:

  1. Known to have hematological disorders or other diseases that cause anemia other than chronic kidney disease (CKD), such as primary pure red cell aplasia (PRCA), homozygous sickle cell disease, thalassemia/Cooley's anemia, multiple myeloma, hemolytic anemia, and myelodysplastic syndrome, or malignant tumors;
  2. Known to be allergic to iron agents or polyethylene glycol;
  3. Received red blood cell or whole blood transfusion therapy within the three months prior to randomization;
  4. Having received or planned to receive anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization or during the study treatment period;
  5. Poorly controlled blood pressure (specific criteria for determination are referenced in Appendix II);
  6. C-reactive protein (CRP) ≥30 mg/L within 7 days prior to randomization;
  7. Pregnant or breastfeeding women, women of childbearing age with a positive urine β-HCG test result prior to the study, or those planning to become pregnant during the study;
  8. Assessed as having Class C liver function within 7 days prior to randomization (Child-Pugh classification, details in Appendix IV);
  9. Assessed as having Class III or IV cardiac function within 28 days prior to randomization (details in Appendix III);
  10. Subjects deemed by the investigator to have any other factors that make them unsuitable for participation in this study.

Where it's running

• Poster
  Dalian, Liaoning, China Recruiting

Study contacts

• Principal investigator: Hongli Lin, M.D. — The First Affiliated Hospital of Dalian Medical University
• Study coordinator: Hongli Lin, M.D.
• Email: linhongli@vip.163.com
• Phone: 13332268576

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Enarodustat for Anemia in Non-Dialysis CKD Patients

  This study tests whether enarodustat can help increase hemoglobin safely in adults with CKD who aren’t on dialysis, grouping participants by inflammation level.

  Recruiting Huashan Hospital · Shanghai, Shanghai Municipality · NCT07741279

• Switching dialysis patients on HIF-PHI to long‑acting pegmolesatide for renal anemia

  This study will test whether switching dialysis patients with renal anemia who are taking HIF‑PHI medication to long‑acting pegmolesatide keeps hemoglobin stable and is safe.

  Recruiting Guangdong Provincial People's Hospital · Beijing, Beijing Municipality and 23 other locations · NCT07136792

• Switching to pegmolesatide for anemia in people on dialysis

  This 24-week test will try whether switching dialysis patients whose anemia isn't at goal from rHuEPO to pegmolesatide alone or combined with roxadustat keeps or raises hemoglobin better than continuing rHuEPO.

  Recruiting Phase 4 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07045155

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.