To compare whether de novo use of belatacept and sirolimus versus tacrolimus and MMF maintenance therapy will prevent the development of DSA or maintain optimal graft function (eGFR).
This is a phase II, multi-center, open label, randomized controlled trial comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and MMF in pediatric kidney transplant recipients.
13-20 years of age and candidate for primary renal allograft from a deceased donor. EBV IgG Seropositive, TB negative, and agreeable to use of FDA approved contraception for study duration. Can't have a diagnosis or history of: Malignancy, anti-HLA antibody to donor, cPRA > 80%, prior history of organ transplant, active systemic autoimmune diseases, idiopathic FSGS, MPGN, C3G, or aHUS, known bleeding disorder, platelet counnt < 75,000 cells/μl, sustained abnormally high liver function tests, or a sustained WBC <1500 or >20,000 per microliter within 3 months of randomization.
Principal Investigator