Long-Term Follow-Up of a Prospective Randomized Trial of Sirolimus and Tacrolimus

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Our objectives are to determine the best long-term immunosuppression protocol for kidney transplant recipients on a steroid-free regimen. Steroids are associated with numerous side effects posttransplant including osteoporosis, avascular necrosis, fractures, cataracts, hypertension, glucose intolerance, and appearance and mood changes. And it is recognized that side effects lead to noncompliance; in transplantation, noncompliance reads to increased rejection and graft loss. We and others have shown that kidney transplants can be successfully done with either complete avoidance or rapid discontinuation of steroids. We will compare long-term outcome of 3 immunosuppressive protocols, all using antibody induction and rapid discontinuation of prednisone: cyclosporine and mycophenolate vs. high (blood) level tacrolimus and low level sirolimus vs. low (blood) level tacrolimus and high level sirolimus. Our main end points will include patient and graft survival, incidence of biopsy-proven chronic allograft nephropathy, and renal function. We will also determine the incidence of complications and the long-term costs of the individual protocols. We will be able to determine whether or not one of these clinical care protocols provides better outcome for kidney transplant recipients.