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

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

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89 Scopus citations

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 (TAG) (8-12 ng/mL)-low-level sirolimus (SRL) (3-7 ng/mL) (n = 72); or low-level TAG (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.

Original languageEnglish (US)
Pages (from-to)1529-1536
Number of pages8
JournalAmerican Journal of Transplantation
Volume5
Issue number6
DOIs
StatePublished - Jun 2005

Keywords

  • Immunosuppression
  • Kidney transplant
  • Prospective
  • Śteroid-free

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