drugset / Trial / NCT06946394
Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not Receiving Dialysis
Phase 4
Not yet recruiting
160 enrolled
The First Affiliated Hospital of Dalian Medical University
Jiangsu Hansoh Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2025-05
- Primary completion
- 2026-06
- Completion
- 2026-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegmolesatide | Peptide | 0.04 mg/kg | Subcutaneous |
| Subject | Pegmolesatide | Peptide | 2 mg | Subcutaneous |
| Subject | Pegmolesatide | Peptide | 3.2 mg | Subcutaneous |