Actively Recruiting
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)
Led by Regeneron Pharmaceuticals · Updated on 2026-04-27
56
Participants Needed
10
Research Sites
276 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has Chronic Kidney Disease (CKD) requiring hemodialysis, and awaiting kidney transplant on the United Network for Organ Sharing (UNOS), with a cPRA 9.9%, or those with a cPRA >98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist
- Adequate hematologic and adequate hepatic function as defined in the protocol
- Willing and able to comply with clinic visits and study-related procedures
You will not qualify if you...
- Current or active malignancy not in remission for at least 1 year
- Central nervous system (CNS) pathology or history of CNS neurodegenerative or movement disorders
- Patients who have had their spleen removed, including patients with functional asplenia
- Patients who have received a stem cell transplantation within 5 years
- Use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger)
- Total plasma IgG <300 mg/dL at screening
- Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone (or anti-inflammatory equivalent) within 72 hours of start of study drug administration
- Received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration
- Received cyclophosphamide, rituximab, obinutuzumab, other anti-CD20 or B cell-depleting agents, or proteasome inhibitors or anti-CD38 therapies (eg, isatuximab, daratumumab) within 12 months of study drug administration
- Prior treatment with any anti-BCMA antibody (including antibody drug conjugate or bsAb) or BCMA-directed CAR-T cell therapy
- Has received a COVID-19 vaccination, as described in the protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
3
Connie Frank Transplant Center at UCSF
San Francisco, California, United States, 94143
Actively Recruiting
4
Yale University of Medicine
New Haven, Connecticut, United States, 06520
Actively Recruiting
5
Medstar Georgetown Transplant Institute - 2-PHC
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
6
Comprehensive Transplant Center
Chicago, Illinois, United States, 60611
Actively Recruiting
7
John Hopkins Hospital
Baltimore, Maryland, United States, 21224
Actively Recruiting
8
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
9
New York University Langone Health
New York, New York, United States, 10016
Actively Recruiting
10
Penn Transplant Institute
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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