TACROLIMUS WITH STEROIDS AND STANDARD DACLIZUMAB VERSUS STEROID-FREE TACROLIMUS

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。 背景和意义： SNS01方案是一项随机(1：1)对比研究，对传统免疫抑制疗法(8周内5剂赛尼帕斯诱导，他克莫司、霉酚酸酯和类固醇)与非类固醇免疫抑制疗法(6个月内9剂赛尼帕斯诱导，他克莫司和霉酚酸酯莫非替尔)进行比较研究。 研究表明，霉酚酸酯(CellCept，MMF)和他克莫司(Prograf)都被血细胞吸收。然而，我们对儿童的药代动力学并不完全了解。 具体目标： SNS01方案的主要目标是比较非类固醇免疫抑制与他克莫司(Prograf)、霉酚酸酯(CellCept)和达克珠单抗(Zenapax)诱导联合应用与类固醇免疫抑制的安全性和有效性。 MPA和他克莫司PK分组研究的具体目的是确定他克莫司和霉酚酸酯在纳入SNS01方案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.