Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis

NCT07759167 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: R9533-HD-25762026-525844-14-00
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

End-Stage Kidney Disease (ESKD)

Keywords

Hemodialysis (HD); Thrombosis; Bleeding; Blood clots; Chronic Kidney Disease (CKD)

Outcome Measures

Primary Outcomes (2)

• Occurrence of Treatment-Emergent Adverse Events (TEAEs)

  Up to approximately 78 days

• Severity of TEAEs

  Up to approximately 78 days

Secondary Outcomes (5)

• Concentrations of REGN9933

  Up to approximately 78 days

• Concentrations of REGN7508

  Up to approximately 78 days

• Concentrations of REGN9533

  Up to approximately 78 days

• Change in activated Partial Thromboplastin Time (aPTT)

  From baseline up to approximately 78 days

• Change in Prothrombin Time (PT)

  From baseline up to approximately 78 days

Study Arms (3)

REGN9933

EXPERIMENTAL

Drug: REGN9933; Drug: Heparin

REGN7508

EXPERIMENTAL

Drug: REGN7508; Drug: Heparin

REGN9533

EXPERIMENTAL

Drug: REGN9533; Drug: Heparin

Interventions

REGN9933 DRUG

Administered per the protocol

Also known as: amrecibart

REGN9933

REGN7508 DRUG

Administered per the protocol

Also known as: cenvacibart

REGN7508

REGN9533 DRUG

Administered per the protocol

REGN9533

Heparin DRUG

Administered per the protocol

REGN7508; REGN9533; REGN9933

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Thrombosis; Hemorrhage; Renal Insufficiency, Chronic

Interventions

Heparin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 9, 2026
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf