CALCINEURIN INHIBITOR SPARING PROTOCOL IN LIVING DONOR PEDIATRIC KIDNEY TRANSPL)

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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.