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

NCT07759167 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-08-12

No results posted yet for this study

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)

Interventions

DRUG

REGN9933

Administered per the protocol

DRUG

REGN7508

Administered per the protocol

DRUG

REGN9533

Administered per the protocol

DRUG

Heparin

Administered per the protocol

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-09
Primary Completion
2027-03-25
Completion
2027-03-25
FDA Drug
Yes

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07759167 on ClinicalTrials.gov