TACROLIMUS WITH STEROIDS AND STANDARD DACLIZUMAB VERSUS STEROID-FREE TACROLIMUS

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 背景和意义： 方案SNS 01是一项传统免疫抑制方案（8周内5剂Zenapax诱导，他克莫司、吗替麦考酚酯和类固醇）与无类固醇免疫抑制方案（6个月内9剂Zenapax诱导，他克莫司和吗替麦考酚酯）的随机（1：1）比较研究。 研究表明，吗替麦考酚酯（CellCept，MMF）和他克莫司（Tacrolimus，TMF）都能被血细胞吸收。 然而，我们并不完全了解儿童的药代动力学。 具体目标： SNS 01方案的主要目的是比较不含类固醇的免疫抑制剂与他克莫司（TMF）、吗替麦考酚酯（CellCept）和达克珠单抗（Zenapax）联合诱导与基于类固醇的免疫抑制剂的安全性和疗效。 MPA和他克莫司PK子研究的具体目的是确定他克莫司和吗替麦考酚酯在入组方案SNS 01的儿童肾移植患者中的生物利用度。

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. BACKGROUND AND SIGNIFICANCE: Protocol SNS01 is a randomized (1:1) comparative study of traditional immunosuppressive regimen (5 doses of Zenapax induction over an 8-week period, tacrolimus, mycophenolate mofetil and steroids) vs. steroid-free immunosuppressive regimen (9 doses of Zenapax induction over a 6-month period, tacrolimus and mycophenolate mofetil). Studies have shown that both mycophenolate mofetil (CellCept, MMF) and tacrolimus (Prograf) are absorbed in blood cells. However, the pharmacokinetics in children we do not completely understood. SPECIFIC AIMS: The primary objective of the SNS01 Protocol is to compare the safety and efficacy of steroid-free immunosuppression, given in combination with tacrolimus (Prograf), mycophenolate mofetil (CellCept) and daclizumab (Zenapax) induction with steroid-based immunosuppression. The specific aim of the MPA and Tacrolimus PK Sub-Study is to determine the bioavailability of tacrolimus and mycophenolate mofetil in pediatric renal transplant patients enrolled in Protocol SNS01.