NCT07759167RecruitingPhase 1
Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 6 Aug 2026
- Start date
- 17 Sept 2026
- Primary completion date
- 2 Apr 2027
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Chronic kidney disease
- NCT number
- NCT07759167
- EU CT number
- 2026-525844-14-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 36
- From 17 Sept 2026 to the primary completion date, 2 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.