End-Stage Kidney Disease (ESKD)Phase 1NCT07759167
Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis
A Phase 1 study testing REGN9933, REGN7508 and REGN9533 in people with End-Stage Kidney Disease (ESKD), run by Regeneron Pharmaceuticals at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Kidney Disease (ESKD)
- What is being tested?
- REGN9933, REGN7508 and REGN9533
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Sep 2026to 2 Apr 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- 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)
- Current use of oral anticoagulants (eg, warfarin, Direct Oral Anti-Coagulant [DOACs]) or dual antiplatelet therapy for clinical indication
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: 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.
Read more
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
- Conditions
- End-Stage Kidney Disease (ESKD)
- Being tested
- REGN9933, REGN7508, REGN9533, Heparin
- Keywords
- Hemodialysis (HD), Thrombosis, Bleeding, Blood clots, Chronic Kidney Disease (CKD)
- Medical subject headings
- Kidney Failure, Chronic, Thrombosis, Hemorrhage, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN9933Drug
Also called amrecibart
Administered per the protocol
REGN7508Drug
Also called cenvacibart
Administered per the protocol
REGN9533Drug
Administered per the protocol
HeparinDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| REGN9933 | Experimental | Not described Receives: Drug: REGN9933; Drug: Heparin |
| REGN7508 | Experimental | Not described Receives: Drug: REGN7508; Drug: Heparin |
| REGN9533 | Experimental | Not described Receives: Drug: REGN9533; Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to approximately 78 days
Severity of TEAEs
Measured: Up to approximately 78 days
Secondary outcomes (5)
Concentrations of REGN9933
Measured: Up to approximately 78 days
Concentrations of REGN7508
Measured: Up to approximately 78 days
Concentrations of REGN9533
Measured: Up to approximately 78 days
Change in activated Partial Thromboplastin Time (aPTT)
Measured: From baseline up to approximately 78 days
Change in Prothrombin Time (PT)
Measured: From baseline up to approximately 78 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start17 Sep 2026
- Primary completion2 Apr 2027 (estimated)
- Study completion2 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759167
- Sponsor's protocol ID
- R9533-HD-2576
- Other IDs
- 2026-525844-14-00
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.