Actively Recruiting
A Noninterventional Extension Study for Patients Treated in Study R5459-RT-1944 With Vonsetamig (BCMA x CD3 Bispecific Antibody) Who Receive a Kidney Transplant
Led by Regeneron Pharmaceuticals · Updated on 2026-04-17
20
Participants Needed
9
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing adult patients with chronic kidney disease who previously received vonsetamig treatment and have now undergone a kidney transplant. The study aims to continue evaluating how vonsetamig behaves in the body and monitor patient outcomes after the transplant. This noninterventional extension study builds on prior research conducted in study R5459-RT-1944. No new study drug will be administered during this observational study. Participants have already received a kidney transplant after acceptable crossmatching while enrolled in the earlier vonsetamig study. The research focuses on monitoring patients without providing additional investigational treatments. Participants will attend clinic visits and undergo study-related procedures to track various health measures after their kidney transplant. Researchers will monitor adverse events and serious adverse events up to 12 months post-transplant. They will also assess kidney rejection episodes, graft loss, kidney function changes, antibody levels, and vonsetamig concentration over time. The study duration extends up to one year following the transplant.
CONDITIONS
Brief Title
An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received at least 1 dose of vonsetamig treatment in study R5459-RT-1944.
- Received a kidney transplant after acceptable crossmatching while enrolled in study R5459-RT-1944.
- Willing and able to attend clinic visits and complete study-related procedures.
- Provided informed consent signed by the patient or legally acceptable representative.
You will not qualify if you...
- There are no exclusion criteria for this study.
- Note: Other protocol-defined inclusion or exclusion criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months post-kidney transplant
Participants who received a kidney transplant after treatment with vonsetamig are observed for safety and kidney function over time.
Regular visits for up to 12 months
Trial Site Locations
Total: 9 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
Comprehensive Transplant Center
Chicago, Illinois, United States, 60611
Actively Recruiting
6
John Hopkins Hospital
Baltimore, Maryland, United States, 21224
Actively Recruiting
7
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
8
New York University Langone Health
New York, New York, United States, 10016
Actively Recruiting
9
Penn Transplant Institute
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
Clinical Trials Administrator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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