Three antibodies plus heparin in adults with end-stage kidney disease on dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, phase 1 study evaluates the safety and pharmacokinetics of three investigational monoclonal antibodies (REGN9933, REGN7508, REGN9533) in adults undergoing hemodialysis for end-stage kidney disease and receiving standard anticoagulation with heparin. Participants will be monitored for side effects and how the drugs behave in the blood, including concentrations over time and effects on clotting. The study also aims to see whether these antibodies influence normal blood clotting while patients continue standard dialysis treatment. Enrollment focuses on stable patients meeting specific health criteria and excludes those with recent major bleeding or other high bleeding risk conditions. Lead sponsor is Regeneron Pharmaceuticals, with study sites at Ghent University Hospital in Belgium.

Why it matters

Who can join: the full rules

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

Where it's running

• Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
  Ghent, Oost-Vlaanderen, Belgium Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.