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

Abstract

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/I in the CsA and NoCsA groups, respectively. Rejection‐free patients of the CsA group had poorer renal function (168 μmol/I) than those of the NoCsA group (121 μmol/I; 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.