Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With En… (NCT07759167) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis
36 participantsStarted 2026-09-09
Plain-language 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 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
. 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