RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT07759167

Registry updated: 2026-10-06

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Description

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

Interventions

REGN9933 (Drug)
Administered per the protocol
REGN7508 (Drug)
Administered per the protocol
REGN9533 (Drug)
Administered per the protocol
Heparin (Drug)
Administered per the protocol

Eligibility criteria

Key Inclusion Criteria: 1. Has ESKD and has regular adherence receiving HD 3 times per week as described in the protocol 2. Is receiving heparin (standard of care) anticoagulation, with no history of intolerability, during each dialysis session 3. Has adequate vascular access 4. Is clinically stable with no hospitalizations in the past 30 days prior to first screening visit as described in the protocol Key Exclusion Criteria: 1. Has history of major bleeding (International Society on Thrombosis and Haemostasis \[ISTH\]) criteria) within the past 3 months prior to the first screening visit as described in the protocol 2. Has known bleeding conditions (eg, Hemophilia A, B or C, von Willebrand's disease) hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy) 3. Current use of oral anticoagulants (eg, warfarin, Direct Oral Anti-Coagulant \[DOACs\]) or dual antiplatelet therapy for clinical indication 4. Heart failure as classified by New York Heart Association (NYHA) class III or IV 5. Has a sustained uncontrolled hypertension as described in the protocol Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Conditions

End-Stage Kidney Disease (ESKD)

Locations

Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital — Ghent, Oost-Vlaanderen, Belgium

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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