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A Prospective Randomized Trial of Steroid-Free Maintenance Regimens in Kidney Transplant Recipients—An Interim Analysis
Authors:Raja Kandaswamy   J. Keith Melancon  Ty 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
Affiliation:Department of Surgery, University of Minnesota, Minneapolis, USA. kanda003@umn.edu
Abstract: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.
Keywords:Immunosuppression    kidney transplant    prospective    śteroid-free
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