A RANDOMIZED, MULTI-CENTER COMPARATIVE TRIAL OF TACROLIMUS WITH STEROIDS

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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. This protocol will compare the safety and efficacy of steroid-free immunosuppression, given in combination with Prograf¿¿ (tacrolimus), CellCept¿¿ (MMF) and Zenapax¿¿ (daclizumab) induction with steroid-based immunosuppression in pediatric subjects, ages 0 to 21 years, receiving a primary kidney transplant from a cadaveric or living donor. The primary efficacy endpoint is the difference in the change of standardized height at one year; the primary safety outcome is the rate at 12 months of biopsy proven acute rejection.