EXPLORATORY STUDY FUNCTIONS OF INDUCTION THERAPY FOR THE IMMUNOMODULATORY

免疫调节诱导治疗功能的探索性研究

• 批准号: 7379425
• 负责人: RUTH C MCDONALD
• 金额: $ 1.9万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379425
• 关键词: EXPLORATORY; STUDY; FUNCTIONS; INDUCTION; THERAPY

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. Pediatric recipients of renal transplants currently have excellent short-term outcomes, but long-term success is compromised by the complications of chronic immunosuppressive medications and by chronic rejection. The overall goal of our proposal is to optimize short and long-term renal allograft function with minimal chronic immunosuppression. Studies have indicated that calcineurin inhibitors (Cyclosporine and Tacrolimus) and corticosteroids (prednisone), the immunosuppressives with the most harmful side effects, can be individually avoided in pediatric renal transplantation1, 2, 3. There have been few prospective, randomized, controlled trials of immunosuppression for children. In the past, drugs were tested only in adults and their use had been extrapolated to children. This research study proposes to evaluate the safety of using Campath-1H, a T-cell inhibitor, for induction in pediatric transplant recipients. This study is a multi-center, Phase II, open-label, single-arm trial in which recipients of renal allografts receive a uniform immunosuppressive induction and maintenance regimen. Campath-1H will be given immediately pre and post transplant intravenously. For the first 8-12 weeks post operative, the transplant recipient will receive Tacrolimus and Mycophenolate Mofetil (MMF), and then convert to a maintenance regimen of Sirolimus and MMF.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。目前，肾移植的儿科受者具有良好的短期结果，但长期成功受到慢性免疫抑制药物并发症和慢性排斥反应的影响。我们建议的总体目标是优化短期和长期肾移植功能，最小的慢性免疫抑制。研究表明，钙调磷酸酶抑制剂（环孢素和他克莫司）和皮质类固醇（泼尼松），免疫抑制剂与最有害的副作用，可以单独避免在小儿肾移植1，2，3。很少有关于儿童免疫抑制的前瞻性、随机、对照试验。在过去，药物只在成人中进行测试，其使用被推断为儿童。本研究旨在评估使用Campath-1H（一种T细胞抑制剂）诱导儿科移植受者的安全性。本研究是一项多中心、II期、开放标签、单臂试验，其中肾移植受者接受统一的免疫抑制诱导和维持方案。Campath-1H将在移植前后立即静脉注射。 对于术后的前8-12周，移植受体将接受他克莫司和吗替麦考酚酯（MMF），然后转换为西罗莫司和MMF的维持方案。