RANDOMIZED, MULTICENTER COMPARATIVE TRIAL OF TACROLIMUS WITH STEROIDS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项方案将在接受身体或活体肾移植的0至21岁的儿科受试者中比较非类固醇免疫抑制与类固醇免疫抑制的安全性和有效性，这些免疫抑制与他克莫司、CellCept(MMF)和Zenapax(Daclizumab)诱导联合给予。主要的疗效终点是一年内标准化身高变化的差异；主要的安全结果是活检证实的急性排斥反应12个月的发生率。

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.