NCT06946394RecruitingPhase 4
Use of Pegmolesatide in Renal Anemia: Efficacy and Safety of Switching to Pegmolesatide in Non-dialysis CKD Patients Treated With rhuEPO or HIF-PHI
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 10 Nov 2024
- Start date
- 1 May 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Diseases
- Chronic kidney disease
- NCT number
- NCT06946394
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 160
- From 1 May 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion Criteria:
- Aged ≥18 years and ≤80 years, regardless of gender;
- Body weight ≥45 kg; Body Mass Index (BMI) ≥18.5 kg/m²;
- 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;
- Hemoglobin (Hb) level measured within 7 days before randomization ≥70 g/L and \< 110 g/L;
- Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF)
- Exclusion Criteria:
- 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;
- Known to be allergic to iron agents or polyethylene glycol;
- Received red blood cell or whole blood transfusion therapy within the three months prior to randomization;
- Having received or planned to receive anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization or during the study treatment period;
- Poorly controlled blood pressure (specific criteria for determination are referenced in Appendix II);
- C-reactive protein (CRP) ≥30 mg/L within 7 days prior to randomization;
- 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;
- Assessed as having Class C liver function within 7 days prior to randomization (Child-Pugh classification, details in Appendix IV);
- Assessed as having Class III or IV cardiac function within 28 days prior to randomization (details in Appendix III);
- Subjects deemed by the investigator to have any other factors that make them unsuitable for participation in this study.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Poster Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.