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A Prospective Randomized Trial of Steroid-Free Maintenance Regimens in Kidney Transplant Recipients—An Interim Analysis

2005; Elsevier BV; Volume: 5; Issue: 6 Linguagem: Inglês

10.1111/j.1600-6143.2005.00885.x

1600-6143

Raja Kandaswamy, J. Keith Melancon, Ty B. Dunn, Miguel Tan, Vincent Casingal, Abhinav Humar, William D. Payne, Rainer W.G. Gruessner, David L. Dunn, John S. Najarian, David E.R. Sutherland, Kristen J. Gillingham, Arthur J. Matas,

Transplantation: Methods and Outcomes

We compared three maintenance immunosuppressive regimens in a rapid discontinuation of prednisone protocol. From March 1, 2001, through December 31, 2003, 239 first and second kidney transplant recipients (166 LD; 73 DD) were randomized. All recipients were treated with Thymoglobulin; all received steroids intraoperatively and for 5 days postoperatively. Randomization was to cyclosporine–mycophenolate mofetil (n = 85); high-level tacrolimus (TAC) (8–12 ng/mL)–low-level sirolimus (SRL) (3–7 ng/mL) (n = 72); or low-level TAC (3–7 ng/mL)–high-level SRL (8–12 ng/mL) (n = 82). We found no difference at 24 months between groups in patient, graft, death-censored graft, or acute rejection-free graft survival, or in kidney function. Wound complications were more common in SRL-treated recipients (p = 0.02); we found no other differences between groups in complication rates. Our data suggest that excellent patient and graft survival and low rejection rates can be obtained using a variety of maintenance protocols without prednisone.