CLINICAL TRIAL: A RANDOMIZED, MULTI-CENTER COMPARATIVE TRIAL OF TACROLIMUS WITH

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 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.