N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 4 ClinicalTrials.gov

Use of Pegmolesatide in Renal Anemia: Efficacy and Safety of Switching to Pegmolesatide in Non-dialysis CKD Patients Treated With rhuEPO or HIF-PHI

Sponsor: The First Affiliated Hospital of Dalian Medical University • ClinicalTrials.gov ID: NCT06946394

Registry updated: 2026-09-02
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients which had received Recombinant human erythropoietin (rHuEPO) or Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) treatment were randomized in a 1:1 ratio to receive Pegmolesatide with different administration regimens.

Interventions

  • Pegmolesatide (Drug)
    Pegmolesatide Injection: Specification 1mL: 4.0mg (National Medical Products Administration Approval No. H20230020), administered once every 4 weeks

Eligibility criteria

* 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.

Conditions

Renal Anemia in Non-dialysis Chronic Kidney Disease

Locations

  • Poster — Dalian, Liaoning, China
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record