Advancing Transplantation Outcomes in Children

Recruiting Phase 2 Interventional Study
Kidney Transplant
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
13 – 20
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
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About This Trial

This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participant and/or parent/guardian must be able to understand and provide informed consent 2. Male or female, 13-20 years of age at time of enrollment 3. Candidate for primary renal allograft from a living or deceased donor 4. EBV IgG seropositive, defined as evidence of acqu…
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