Tacrolimus and mycophenolate mofetil in renal transplant recipients: one year results of a multicenter, randomized dose ranging trial

TrialJ. Miller, for the FK506/MMF Dose-Ranging Kidney Transplant Study Group R ECENT results of FK506 multicenter kidney trans- plant studies conducted in the United States and Europe showed that tacrolimus significantly reduced that incidence and severity of biopsy-proven acute rejection as compared to cyclosporine A (CyA).1,2 Mycophenolate mofetil (MMF, CellCept) was introduced to the market in 1995 for the prophylaxis of organ rejection in patients receiving allogenic renal transplants.Randomized controlled studies showed a benefit of MMF at doses of 2 g/day and 3 g/day when used with CyA in preventing acute rejection episodes.3,4 Currently, MMF is recommended for use as an immunosuppressant in conjunction with cyclosporine; however, MMF has not been sufficiently tested in concomitant administration with tacrolimus.The present study evaluates the safety and efficacy of two different initial doses of MMF (1 g/day and 2 g/day) versus azathioprine (AZA) when used in combination with tacrolimus and corticosteroids in cadaveric renal transplant recipients.