A PLACEBO CONTROLLED STUDY OF MYCOPHENOLATE MOFETIL USED IN COMBINATION WITH CYCLOSPORINE AND CORTICOSTEROIDS FOR THE PREVENTION OF ACUTE REJECTION IN RENAL ALLOGRAFT RECIPIENTS: 1-YEAR RESULTS

AbstractPurpose: We performed a randomized, double-blind, multicenter, placebo controlled study to compare the efficacy and safety of 2 oral doses of mycophenolate mofetil with placebo for prevention of acute rejection episodes following first or second cadaveric renal allograft transplantation.Materials and Methods: A total of 491 patients were enrolled in the study and randomly allocated to receive placebo (166), 1 gm. mycophenolate mofetil twice daily (165) or 1.5 gm. mycophenolate mofetil twice daily (160). Patients were given concomitant immunosuppression with cyclosporine and corticosteroids. Treatment with mycophenolate mofetil was initiated within 72 hours of transplantation and was continued for at least 1 year.Results: The percentages of patients who experienced biopsy proved rejection or withdrew early from the trial for any reason were significantly reduced with 2 gm. (30.3%) and 3 gm. (38.8%) mycophenolate mofetil compared to placebo (56.0%) (p <0.001). The biopsy proved rejection rates of th...