Kidney Failure Clinical Trial
Official title:
Exploring the Impact of de Novo Everolimus on Key Determinants of Long Term Outcome After Kidney Transplantation: NODAT, Viral Infection, DSA, Proteinuria and Graft Histology
CRAD001AAU13 is a substudy of CRAD001A2433. The core study CRAD001A2433 is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating graft function with everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients. Patients in this study may use cyclosporine or tacrolimus as the CNI.
Patients enrolled in the core study CRAD001A2433 in Australia will be eligible for recruitment into CRAD001AAU13. These patients will undergo additional tests (including 4 kidney allograft biopsies) as part of the substudy that will be conducted during core study CRAD001A2433 visits. At Day 0 (day of transplant /TX), Month 2, Month 12 and Month 24 additional samples (serum, whole blood and kidney biopsy) will be taken for the purposes of this substudy. ;
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