Tests 3 antibody drugs in adults with kidney failure on dialysis
Tests REGN9933, REGN7508 and REGN9533 for safety in adults on hemodialysis.
Plain-language title generated from the registry record
Registry title: Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis
Key facts
- Where
- Ghent, BelgiumSee the site
- Phase
- Phase 1
Where in Belgium
- Universitair Ziekenhuis (UZ) Gent/ Ghent University HospitalGhent, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT07759167EU 2026-525844-14-00
- Record updated
- 6 October 2026
- Original description
This study will evaluate three Investigational Medicinal Products (IMPs) called REGN9933, REGN7508, and REGN9533.Read full original descriptionShow less
A Master Protocol for a Phase 1b Double-Blind, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 and REGN7508, Factor XI Monoclonal Antibodies, and REGN9533, a Factor XII Monoclonal Antibody, in Participants With End-Stage Kidney Disease on Hemodialysis
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
Inclusion: Has ESKD and has regular adherence receiving HD 3 times per week as described in the protocol; Is receiving heparin (standard of care) anticoagulation, with no history of intolerability, during each dialysis session; Has adequate vascular access; Is clinically stable with no hospitalizations in the past 30 days prior to first screening visit as described in the protocol.
Exclusion: 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; Current use of oral anticoagulants (eg, warfarin, Direct Oral Anti-Coagulant [DOACs]) or dual antiplatelet therapy for clinical indication; 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); Heart failure as classified by New York Heart Association (NYHA) class III or IV; Has a sustained uncontrolled hypertension as described in the protocol; Note: Other protocol-defined Inclusion/ Exclusion criteria apply.