Triple immunosuppressant therapy with cyclosporine (CsA), prednisone, and either azathioprine or, more recently, mycophenolate mofetil (MMF) is used in most transplant centers for renal transplantation. These drugs have different mechanisms of action and different toxicities. It has been observed that many patients do well with only two immunosuppressant agents late after renal transplantation, however, there are no controlled comparative trials of the withdrawal of immunosuppressant agents. This is an open label, randomized, controlled, therapeutic comparison trial. All patients will be treated with standard maintenance immuno- suppression during the first year after transplantation. At 12 months patients will be receiving MMF (1 g bid), CsA, and prednisone. Patients will be randomly allocated to 3 groups. Enrollment will occur 12-15 months after renal transplantation and follow-up will be for 2 years for evaluation of renal function and 5 years for those patients who agree to undergo allograft biopsies at baseline and 5 years after withdrawal. Patients allocated to group I will undergo withdrawal of CsA over 12 weeks, patients in Group II will be taken off prednisone over 12 weeks and patients in group III will discontinue MMF. At the time of CsA cessation in Group I, prednisone will be increased to 40 mg qd for one week, 30 mg for one week, then returned to baseline. At 3 months after CsA cessation the prednisone will be further reduced to 7.5 mg qd or 15 mg qod. In Group II, the CsA target blood level will be reduced from 125-175 to 75-125 at 3 months after prednisone withdrawal. In Group III, the prednisone dosing will be the same as for group I, except that no flare of prednisone will be given when MMF is stopped.
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