STUDY THE IMMUNOMODULATORY FUNCTION OF INDUCTION THERAPY OF CAMPATH-1H

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Pediatric recipients of renal transplants currently have excellent short-term outcomes, but long-term success is compromised by the complications of chronic immunosuppressive medications and by chronic rejection. The overall goal of our proposal is to optimize short and long-term renal allograft function with minimal chronic immunosuppression. Studies have indicated that calcineurin inhibitors (Cyclosporine and Tacrolimus) and corticosteroids (prednisone), the immunosuppressives with the most harmful side effects, can be individually avoided in pediatric renal transplantation 1, 2, 3. There have been few prospective, randomized, controlled trials of immunosuppression for children. In the past, drugs were tested only in adults and their use had been extrapolated to children. This research study proposes to evaluate the safety of using Campath-1H, a T-cell inhibitor, for induction in pediatric transplant recipients. This study is a multi-center, Phase II, open-label, single-arm trial in which recipients of renal allografts receive a uniform immunosuppressive induction and maintenance regimen. Campath-1H will be given immediately pre and post transplant intravenously. For the first 8-12 weeks post operative, the transplant recipient will receive Tacrolimus and Mycophenolate Mofetil (MMF), and then convert to a maintenance regimen of Sirolimus and MMF.