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A prospective randomized trial of steroid-free maintenance regimens in kidney transplant recipients--an interim analysis.

Research paper by Raja R Kandaswamy, J Keith JK Melancon, Ty T Dunn, Miguel M Tan, Vincent V Casingal, Abhinav A Humar, William D WD Payne, Rainer W G RW Gruessner, David L DL Dunn, John S JS Najarian, David E R DE Sutherland, Kristen J KJ Gillingham, Arthur J AJ Matas

Indexed on: 13 May '05Published on: 13 May '05Published in: American Journal of Transplantation



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.

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