Clinical trial for End-Stage Kidney Disease (ESKD)
Official title Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis
ClinicalTrials.gov ID: NCT07759167
What this study is testing
What is REGN9933?
an investigational medicine being studied as a potential treatment to reduce blood clot risk in patients with end‑stage kidney disease on hemodialysis
Also referred to as amrecibart.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out what side effects the antibodies cause and how they affect blood clotting and drug levels in the body.
- Who it's for
- Adults with end‑stage kidney disease who are receiving regular hemodialysis and standard blood‑thinner medication.
- What's involved
- Participants will receive one of the three study antibodies during dialysis and will have blood samples taken to check drug levels and clotting function.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 Key
You likely can't join if
- Has history of major bleeding (International Society on Thrombosis and Haemostasis [ISTH]) criteria) within the past 3 months prior to the first...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Ghent, Oost-Vlaanderen, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ghent, Oost-Vlaanderen, Belgium. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.