RANDOMIZED, MULTICENTER COMPARATIVE TRIAL OF TACROLIMUS WITH STEROIDS

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。该方案将比较无类固醇免疫抑制联合Prograf（他克莫司）、CellCept （MMF）和Zenapax （daclizumab）诱导与基于类固醇的免疫抑制在0 - 21岁接受尸体或活体肾脏移植的儿童受试者中的安全性和有效性。主要疗效终点为1年标准化身高变化的差异；主要的安全性指标是12个月活检证实的急性排斥反应率。

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.