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A Prospective Randomized Trial of Steroid‐Free Maintenance Regimens in Kidney Transplant Recipients—An Interim Analysis
Author(s) -
Kandaswamy Raja,
Melancon J. Keith,
Dunn Ty,
Tan Miguel,
Casingal Vincent,
Humar Abhinav,
Payne William D.,
Gruessner Rainer W. G.,
Dunn David L.,
Najarian John S.,
Sutherland David E. R.,
Gillingham Kristen J.,
Matas Arthur J.
Publication year - 2005
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/j.1600-6143.2005.00885.x
Subject(s) - medicine , thymoglobulin , prednisone , discontinuation , tacrolimus , interim analysis , kidney transplantation , randomization , urology , sirolimus , randomized controlled trial , surgery , maintenance therapy , transplantation , gastroenterology , chemotherapy
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.