A controlled trial comparing two doses of cyclosporine in conjunction withmycophenolate mofetil and corticosteroids

it is unknown whether the addition of mycophenolate mofetil (MMF) to cyclos porine (CsA) and prednisone after renal transplantation (RTx) allows for a reduced dose of CsA, to minimize the incidence of CsA-related side effects and to reduce costs. Therefore, 313 renal allograft recipients were randomi zed for treatment with MMF (1000 mg twice a day), prednisone, and either co nventional- or low-dose CsA during the first 3 mo after RTx. The target tro ugh levels were 300 and 150 ng/ml, respectively, during the first 3 mo and 150 ng/ml in both groups thereafter. A total of 313 patients were included: 161 patients received a conventional dose and 152 received a low dose of C sA. During the first 6 mo after RTx, graft failure or patient death occurre d in 19 of 161 patients (12%) in the conventional-dose group and in 11 of 1 52 patients (7%) in the low-dose group (not significant). Biopsy-proven acu te rejection occurred in 36 of 161 patients (22%) in the conventional dose group and in 29 of 152 patients (19%) in the low-dose group (not significan t). The incidence of delayed graft function was similar in both groups (31 of 161 [19%] versus 28 of 152 [18%]; not significant). Serum creatinine did not differ between the conventional- and the low-dose groups: 151 +/- 56 m u mol/L versus 142 +/- 49 mu mol/L at 3 mo and 141 +/- 60 mu mol/L versus 1 36 +/- 49 mu mol/L at 6 mo. There were no differences between the groups re garding BP, lipid metabolism, and infectious complications. In the low-dose group, an estimated $500 per patient was saved on the costs of CsA. In con clusion, the addition of MMF to CsA and prednisone after RTx allows the use of a lower-than-conventional dose of CsA, without increasing the risk of r ejection.