SNS01: A RANDOMIZED, MULTI-CENTER COMPARITAVE TRIAL OF TACROLIMUS WITH STEROIDS

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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 multi-center study will use randomized, open-label, parallel group design. Subjects will be randomized (1:1) to a traditional steroid-based immunosuppression regimen (steroids, standard daclizumab induction, Prograf and CellCept) or to a steroid-free immunosuppression regimen (prolonged daclizumab until the sixth month post-transplant, Prograf and CellCept). The primary efficacy endpoint of the study is change in standardized height at 1 year. The primary safety endpoint is the rate at 12 months of biopsy-proven acute rejection. Patient accrual goal is 130 patients, 65 in each group, during an 18 month accrual period from all participating centers. The anticipated number of patients from Children's Hospital is 15. The total number of 130 has been deemed sufficient by NIH to achieve the goals of the study. The duration of follow-up is 3 years. The major inclusion criteria are: 1) age less than 21 years; 2) receiving first kidney transplant. The major exclusion criteria are: 1) steroid treatment within 6 months prior to transplantation; 2) pregnant or lactating; 3) receiving investigational drugs. Subject recruitment process: all patients receiving kidney transplants at Children's Hospital who qualify for the study will be offered an opportunity to paticipate after the medication protocols are explained to the patients and their guardians. If they decline, the standard immunosuppressive protocol will be used. All treatments in both arms will follow current standard of care practices. All subjects in both arms will undergo a percutaneous biopsy of the transplant kidney at transplant, 6, 12, and 24 months after the transplant for documentation of drug toxicity and subclinical rejection. This is a deviation of standard of care in most centers. However, most kidney transplant patients at Children's Hospital undergo 2-5 kidney biopsies during the first 2 years after transplant because of clinical concerns.