Actively Recruiting
Observational Study Following Adults Treated with Vonsetamig in Study R5459-RT-1944 After Kidney Transplant
Led by Regeneron Pharmaceuticals · Updated on 2026-07-20
20
Participants Needed
9
Research Sites
36 weeks
Total Duration
AI-Summary
What this Trial Is About
This observational study follows adult participants with chronic kidney disease who previously received vonsetamig treatment in study R5459-RT-1944 and have since undergone a kidney transplant. The main goal is to continue monitoring how vonsetamig behaves in the body and to observe outcomes after the transplant without administering any new study drugs. Participants are not given any investigational treatments during this extension study. The study focuses on observing patients who received vonsetamig and a kidney transplant under the prior trial. Monitoring will continue up to 12 months post-transplant to assess safety and transplant-related outcomes. During the study, participants will attend clinic visits for evaluations including monitoring adverse events, kidney function through estimated glomerular filtration rate, biopsy-proven rejection, graft loss, and antibody levels. Blood tests will measure serum concentrations of immunoglobulins and vonsetamig. The study duration extends up to one year after the kidney transplant to gather comprehensive safety and efficacy data.
CONDITIONS
Brief Title
An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant
Research Team
C
Clinical Trials Administrator
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