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NCT Number: NCT07759167

Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult 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.

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

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Key information

Conditions

End-Stage Kidney Disease (ESKD) Cardiovascular Diseases Chronic Disease Disease Attributes Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Thrombosis Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Key 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
  • 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

Treatment and study plan

REGN9933

Drug

Administered per the protocol

Other names: amrecibart

REGN7508

Drug

Administered per the protocol

Other names: cenvacibart

REGN9533

Drug

Administered per the protocol

Heparin

Drug

Administered per the protocol

Primary outcomes

  1. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 78 days

  2. Severity of TEAEs

    Time frame: Up to approximately 78 days

Secondary outcomes

  1. Concentrations of REGN9933

    Time frame: Up to approximately 78 days

  2. Concentrations of REGN7508

    Time frame: Up to approximately 78 days

  3. Concentrations of REGN9533

    Time frame: Up to approximately 78 days

  4. Change in activated Partial Thromboplastin Time (aPTT)

    Time frame: From baseline up to approximately 78 days

  5. Change in Prothrombin Time (PT)

    Time frame: From baseline up to approximately 78 days

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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