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. This protocol aims to remove the morbidity of chronic steroid usage that has traditionally accompanied solid organ transplantation. This study specifically targets the pediatric kidney transplant population, one of the most immunogenic solid organ groups, where steroid avoidance has been historically complicated by loss of transplant function and occasionally outright graft loss. Steroid minimization alone has failed to make a positive impact on growth in children, and transulant recipients suffer from hypertension, high lipids, diabetes, bone loss, cosmetic disfigurement and cataracts - all directly related to chronic steroid use. This study proposes to replace steroids with a first ever approach of prolonged induction with daclizumab, until the sixth post-transplant month. Daclizumab will be the investigational product for evaluation in this study. Subjects will be randomized 1:l to a traditional steroid-based immunosuppression regimen (steroids, standard daclizumab induction until the second month post transplant, prograf, and cellcept) or a steroid-free immunosuppression regimen (prolonged daclizumab induction until the sixth month post-transplant, prograf and cellcept). The primary safety endpoint is the rate at 12 months of biopsy proven acute rejection. Renal transplant biopsies will be performed at month 6, 12, and 24 post transplant. There will also be a sample obtained at time of transplant. In the event of a biopsy proven rejection, a repeat biopsy will be perfomed within 1 month unless clinically contraindicated.
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