Two-year observation of a randomized trial on tacrolimus-based therapy with withdrawal of steroids or mycophenolate mofetil after renal transplantation.

OBJECTIVE: To evaluate the safety and feasibility of steroid or mycophenolate mofetil (MMF) withdrawal from tacrolimus-based immunosuppressant regimen in renal allograft recipients. METHODS: A cohort of 45 patients following cadaveric renal allograft transplantation were randomly divided into 3 groups based on the regimen of combination of tacrolimus, steroid, and MMF: triple therapy group, steroid withdrawal group, and MMF withdrawal group. During 2 years, survival of patients and allografts, clinical acute rejection, adverse events, hepatic and renal allograft function, and blood lipids were monitored to evaluate the safety and feasibility of steroid or MMF withdrawal after renal transplantation. RESULTS: During two-year observation, steroid or MMF was successfully withdrawn from immunosuppressant regimen based on tacrolimus without any clinical acute rejection. Patient and graft survival rates were 100% and all the renal allografts kept excellent function. Some adverse events occurred and there were no significant differences among groups. CONCLUSION: Withdrawal of steroid or MMF in low-immunological-risk renal allografts treated with tacrolimus-based immunosuppressant regimen can be achieved with no increased risk of acute rejection.