Tests pegmolesatide for anemia in adults with chronic kidney disease not on dialysis
Tests switching to pegmolesatide in adults with kidney-related anemia not on dialysis.
Plain-language title generated from the registry record
Registry title: Use of Pegmolesatide in Renal Anemia: Efficacy and Safety of Switching to Pegmolesatide in Non-dialysis CKD Patients Treated With rhuEPO or HIF-PHI
Key facts
- Where
- Dalian, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06946394, who can take part
Where in China
- PosterDalian, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Dalian Medical University
- Trial code
- NCT06946394
- Record updated
- 2 September 2026
- Original 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.Read full original descriptionShow less
Use of Pegmolesatide in Renal Anemia: Efficacy and Safety of Switching to Pegmolesatide in Non-dialysis CKD Patients Treated With rhuEPO or HIF-PHI
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.
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.