A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)
NCT05092347 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2026-04-27
Summary
The purpose of this study is to determine whether vonsetamig will safely decrease anti-HLA antibodies to allow for kidney transplantation.
Vonsetamig is being studied for treatment of patients in need of kidney transplantation who are highly sensitized to HLA.
The study is looking at several other research questions, including:
* Side effects that may be experienced from taking vonsetamig
* How vonsetamig works in the body
* How much vonsetamig is present in the blood
* If vonsetamig works to lower levels of antibodies to HLA
Conditions
- Chronic Kidney Disease (CKD)
Interventions
- DRUG
-
Vonsetamig
Administered by intravenous (IV) infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-02
- Primary Completion
- 2027-11-22
- Completion
- 2027-11-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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