Randomized trial of cyclosporine and tacrolimus therapy with steroid withdrawal in living-donor renal transplantation: 5-year follow-up

Abstract

The aim of this study was to compare the long-term safety and efficacy of immunosuppressive regimens consisting of cyclosporine (CsA) plus mycophenolate mofetil (MMF) or tacrolimus (TAC) plus MMF after steroid withdrawal 6 months after kidney transplantation in low-risk patients. One hundred and thirty-one patients were randomized to receive either CsA (n = 63) or TAC (n = 68). Of these, 117 patients satisfied the criteria for steroid withdrawal (no biopsy-proven rejection episode and serum creatinine level <2.0 mg/dl 6 months after transplantation). Fifty-five recipients were of the CsA group, and 62 were of the TAC group. The 5-year graft survival rate did not differ between groups (90.5% vs. 93.3% respectively; P = 0.55). The cumulative incidence of acute rejection 5 years after transplantation was 16.4% and 8.1% for the CsA and TAC groups respectively (P = 0.15). Post-transplantation diabetes mellitus was more frequent in the TAC group than in the CsA group (P = 0.05), but the incidence of other side-effects did not differ between groups. In conclusion, CsA- and TAC-based regimens in conjunction with MMF have similar patient- and graft survival rates in low-risk patients who underwent steroid withdrawal 6 months after kidney transplantation.

Trial registration: ClinicalTrials.gov NCT00777933.