CALCINEURIN INHIBITOR SPARING PROTOCOL IN LIVING DONOR PEDIATRIC KIDNEY TRANSPL)

活体供体儿童肾移植中钙调磷酸酶抑制剂保留方案）

• 批准号: 7379403
• 负责人: RUTH C MCDONALD
• 金额: $ 0.17万
• 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/7379403
• 关键词: CALCINEURIN; INHIBITOR; SPARING; PROTOCOL; LIVING

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 entails the avoidance of calcineurin inhibitors for immunosuppression. The advantages of avoiding these medications are several. Importantly, the calcineurin inhibitors have been implicated in the pathogenesis of PTLD and the avoidance may lessen the risk of this serious and frequently fatal complication. Importantly, both cyclosporine and tacroliums cause acute and chronic nephrotoxicity which may shorten overall kidney graft half-lives substantially. Furthermore they also have other serious side effects, specifically the enhancement of post transplant diabetes, neurotoxicity and, especially in the case of cyclosporine, cosmetic changes which may encourage non-compliance. Since the use of Sirolimus for immunosuppression has not associated with any of these complications, we expect that transplantation in children treated with this protocol will have fewer complications and may have longer kidney half-lives. Eligible participants include those who are 21 years of age or younger receiving their first or second renal transplant. HLA identical transplants are excluded. Subjects with familial abnormalities of lipid metabolism or levels are not eligible. This protocol will provide data on the safety and efficacy of the calcineurin sparing protocol in children. The clinical studies will be coupled by intense immunologic monitoring which are necessary to better understand the graft function, graft morphology and the immunologic status of the recipient. One of the major aims of this trial is to develop a battery of assays that can be utilized to provide a better understanding of the immunologic status of the recipient.

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。该方案需要避免用于免疫抑制的钙调磷酸酶抑制剂。避免这些药物的好处有几个。重要的是，钙调磷酸酶抑制剂与PTLD的发病机制有关，避免使用可能会降低这种严重且经常致命的并发症的风险。 重要的是，环孢霉素和他可引起急性和慢性肾毒性，这可能会大大缩短整个肾移植物的半衰期。此外，它们还具有其他严重的副作用，特别是增强移植后糖尿病、神经毒性，以及尤其是在环孢霉素的情况下，可能鼓励不依从的美容改变。由于使用西罗莫司进行免疫抑制与任何这些并发症无关，我们预计采用该方案治疗的儿童移植并发症较少，肾脏半衰期可能较长。符合条件的参与者包括21岁或以下接受首次或第二次肾移植的患者。排除HLA相同的移植物。具有家族性脂质代谢或水平异常的受试者不合格。本方案将提供钙调磷酸酶保留方案在儿童中的安全性和有效性数据。临床研究将结合强烈的免疫监测，这是必要的，以更好地了解移植功能，移植物形态和受体的免疫状态。本试验的主要目的之一是开发一系列检测方法，可用于更好地了解受体的免疫状态。