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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 2026 → Dec 2026
See other at-risk trials from The First Affiliated Hospital of Dalian Medical University

Record History

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  1. Recruitment openedv2 Show 7 more changesShow less
    • Primary completion pushed from Jun 2026 to Dec 2026
    • Study completion pushed from Nov 2026 to Dec 2027
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2025 to May 1, 2025
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 14 to 17
    • Study title expanded, about 6 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06946394
Lead Sponsor The First Affiliated Hospital of Dalian Medical University
Collaborators: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Renal Anemia in Non-dialysis Chronic Kidney Disease
Related terms Anemia
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov