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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88 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 1 2005

Keywords

  • Immunosuppression
  • Kidney transplant
  • Prospective
  • Śteroid-free

ASJC Scopus subject areas

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)

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    Kandaswamy, R., Melancon, J. K., Dunn, T., Tan, M., Casingal, V., Humar, A., Payne, W. D., Gruessner, R. W. G., Dunn, D. L., Najarian, J. S., Sutherland, D. E. R., Gillingham, K. J., & Matas, A. J. (2005). A prospective randomized trial of steroid-free maintenance regimens in kidney transplant recipients - An interim analysis. American Journal of Transplantation, 5(6), 1529-1536. https://doi.org/10.1111/j.1600-6143.2005.00885.x