RANDOMIZED COMPARATIVE TRIAL OF PROGRAF (TACROLIMUS) IN COMBINATION WITH AZATHIOPRINE OR MYCOPHENOLATE MOFETIL VS. NEORAL (CYCLOSPORINE) WITH MYCOPHENOLATE MOFETIL AFTER KIDNEY TRANSPLANTATION

930 A randomized three-arm parallel group open label prospective study was performed at 15 U.S. centers to compare the safety and efficacy of 3 immunosuppressive regimens: Prograf + MMF vs. Prograf + AZA vs. Neoral + MMF, after first cadaveric kidney transplant. All patients received the same maintenance steroid regimen and only patients with DGF (32%) received antilymphocyte induction. Prograf was dosed to achieve target trough levels of 8-16 ng/ml in the first 3 months and 5-15 ng/ml thereafter. Neoral was dosed to achieve target trough levels of 200-400 ng/ml for the first 3 months and 100-300 ng/ml thereafter. Patients receiving AZA were dosed at 1.5-2.0 mg/kg/day and patients receiving MMF were dosed at 2 grams/day. 223 patients were randomized, transplanted, and followed for 1 year. There were no significant differences in baseline demography between the 3 treatment groups. The 1 year results are as follows: (Table)TableThe only significant differences in laboratory parameters were lower total cholesterol and LDL in the Prograf groups as compared to the Neoral group, and a significantly increased proportion of patients with serum creatinine elevations at 1 year in the Neoral group. The incidence of new onset post transplant diabetes mellitus requiring insulin was Prograf + AZA (14%), Neoral + MMF (7%), and Prograf + MMF (7%). The frequency of serious adverse events including infections were similar across treatment groups. All regimens yielded similar acute rejection rates, but the Prograf + MMF regimen was associated with the lowest rate of steroid resistant rejection. The Prograf regimens were associated with lower rates of hyperlipidemia, and creatinine elevations. The post transplant diabetes rate was similar in the Neoral + MMF and Prograf + MMF groups. This research was funded by Fujisawa Healthcare, Deerfield, Illinois.