Long-term results of a prospective randomized study comparing two immunosuppressive regimens, one with and one without CsA, in low-risk renal transplant recipients

. Due to the nephrotoxicity of cyclosporin A (CsA), its benefit on long-term graft survival remains controversial, especially in low-risk patients. Here we report the 12-year results of a calcineurin-inhibitor-free regimen. One hundred and seventeen low-risk kidney recipients were prospectively randomized to maintenance therapy with either a combination of azathioprine and prednisone (group NoCsA, n =58), or with cyclosporine, azathioprine, and prednisone (group CsA, n =59). Both groups received induction therapy with anti-lymphocyte globulins (ALG). Twelve-year patient survival was 75% and 82.5% in the CsA and NoCsA groups, respectively [ P = not significant (NS)]. Twelve-year graft survival was 59% and 56% ( P =NS) in the CsA and NoCsA groups, respectively (NS). Transplant rejection rates were similar in both groups. Mean serum creatinine levels after 10 years were 161 and 136 μmol/l in the CsA and NoCsA groups, respectively. Rejection-free patients of the CsA group had poorer renal function (168 μmol/l) than those of the NoCsA group (121 μmol/l; P =0.0060). We concluded that a 12-year graft survival of 56% and a graft half-life of 15 years can be achieved without the primary use of a calcineurin inhibitor in low-risk patients receiving ALG. Patients treated with CsA had poorer graft function at 12 years.