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Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Study sites: 0 to 1 · Primary and study completion dates: Mar 25, 2027 to Apr 2, 2027 · Start date changed from estimate of Sep 9, 2026 to Sep 17, 2026 · 1 more Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: Mar 25, 2027 to Apr 2, 2027
    • Start date changed from estimate of Sep 9, 2026 to Sep 17, 2026
    • Eligibility criteria expanded, about 9 words
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
151 trials monitored
See 16 trials at risk
This study will evaluate three Investigational Medicinal Products (IMPs) called REGN9933, REGN7508, and REGN9533. The study is focused on participants with End-Stage Kidney Disease (ESKD) treated with hemodialysis and standard anticoagulant treatment, such as heparin, to reduce the risk of blood clots as they can lead to serious health problems or be life-threatening. Because participants with ESKD who have hemodialysis have a higher risk of bleeding, the IMPs could be a meaningful new therapeutic option. The main aim of the study is to see what side effects may happen from taking REGN9933, REGN7508, or REGN9533. The study is looking at several other research questions, including: * How much IMP is in the blood at different times and * If the IMPs affect the ability of the blood to clot normally
Trial Details
NCT Number NCT07759167
Lead Sponsor Regeneron Pharmaceuticals
Conditions End-Stage Kidney Disease (ESKD)
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov