Triple immunosuppressant therapy with cyclosporine (CsA), prednisone, and azathioprine has been the mainstay of initial maintenance immunosuppression for renal transplantation in the U.S. These drugs have different mechanisms of action and different toxicities. CsA causes scarring of the transplanted kidney in many patients. 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. Mycophenolate mofetil (MMF) when used with CsA and steroids in two large randomized trials reduced the rate of acute rejection in the first year post transplant to about half the rate obtained when CsA/azathioprine/steroids were used. Thus the rate of acute rejection following withdrawal of CsA or steroids will likely be lower with the substitution of MMF for azathioprine. This is an open label, randomized, controlled, therapeutic comparison trial, limited to patients at low risk for acute rejection following a decrease in immunosuppression. The primary hypothesis is that withdrawal of cyclosporine in stable renal allograft recipients 12 months or more after transplantation results in a slower decline in renal function and less kidney scarring than withdrawal of either mycophenolate or prednisone.
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