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Can new antibodies make dialysis safer by preventing clots without bleeding?

NCT ID NCT07759167

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests three experimental antibodies—REGN9933, REGN7508, and REGN9533—in people with end-stage kidney disease who are on hemodialysis. The goal is to see if these antibodies can safely reduce blood clot risk during dialysis, potentially offering an alternative to standard heparin. The study focuses on safety, how the antibodies behave in the body, and their effect on blood clotting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Three experimental monoclonal antibodies (REGN9933, REGN7508, REGN9533) that target clotting proteins, given alongside standard heparin anticoagulation.
What this could lead to
If successful, these antibodies could offer a safer way to prevent blood clots during dialysis, reducing bleeding complications for people with end-stage kidney disease.
What could go wrong
This is an early-phase trial with a small number of participants, so safety and effectiveness are not yet established. The antibodies may not work as hoped or could cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Has ESKD and has regular adherence receiving HD 3 times per week as described in the protocol 2. Is receiving heparin (standard of care) anticoagulation, with no history of intolerability, during each dialysis session 3. Has adequate vascular access 4. Is clinically stable with no hospitalizations in the past 30 days prior to first screening visit as described in the protocol Key Exclusion Criteria: 1. 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 2. 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) 3. Current use of oral anticoagulants (eg, warfarin, Direct Oral Anti-Coagulant \[DOACs\]) or dual antiplatelet therapy for clinical indication 4. Heart failure as classified by New York Heart Association (NYHA) class III or IV 5. Has a sustained uncontrolled hypertension as described in the protocol Note: Other protocol-defined Inclusion/ Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure Hemorrhage thrombotic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End-stage kidney disease (ESKD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.