drugset / Trial / NCT06946394

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

NCT06946394 ↗

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
2025-05-01
Primary completion
2026-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegmolesatide Peptide 0.04 mg/kg Subcutaneous
Subject Pegmolesatide Peptide 2 mg Subcutaneous
Subject Pegmolesatide Peptide 3.2 mg Subcutaneous

Indications

No indication recorded.