Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation

Dixon B. Kaufman, George W. Burke, David S. Bruce, Christopher P. Johnson, A. Osama Gaber, David E.R. Sutherland, Robert M. Merion, Scott A. Gruber, Eugene Schweitzer, John P. Leone, Christopher L. Marsh, Edward Alfrey, Waldo Concepcion, Mark D. Stegall, James A. Schulak, Paul F. Gores, Enrico Benedetti, Craig Smith, Alice K. Henning, Fernando KuehnelSarah King, William E. Fitzsimmons

Research output: Contribution to journalArticle

46 Scopus citations

Abstract

A randomized, multicenter, prospective study was conducted at 18 pancreas transplant centers in the United States to determine the role of induction therapy in simultaneous pancreas-kidney (SPK) transplantation. One hundred and 74 recipients were enrolled: 87 recipients each in the induction and noninduction treatment arms. Maintenance immunosuppression consisted of tacrolimus, mycophenolate mofetil, and corticosteroids. There were no statistically significant differences between treatment groups for patient, kidney, and pancreas graft survival at 1-year. The 1-year cumulative incidence of any treated biopsy-confirmed or presumptive rejection episodes (kidney or pancreas) in the induction and noninduction treatment arms was 24.6% and 31.2% (p=0.28), respectively. The 1-year cumulative incidence of biopsy-confirmed, treated, acute kidney allograft rejection in the induction and noninduction treatment arms was 13.1% and 23.0% (p=0.08), respectively. Biopsy-confirmed kidney allograft rejection occurred later post-transplant and appeared to be less severe among recipients that received induction therapy. The highest rate of Cytomegalovirus (CMV) viremia/syndrome was observed in the subgroup of recipients who received T-cell depleting antibody induction and received organs from CMV serologically positive donors. Decisions regarding the routine use of induction therapy in SPK transplantation must take into consideration its differential effects on risk of rejection and infection.

Original languageEnglish (US)
Pages (from-to)855-864
Number of pages10
JournalAmerican Journal of Transplantation
Volume3
Issue number7
DOIs
StatePublished - Jul 2003

Keywords

  • Immunosuppression
  • Induction therapy
  • Pancreas transplantation

ASJC Scopus subject areas

  • Immunology

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    Kaufman, D. B., Burke, G. W., Bruce, D. S., Johnson, C. P., Gaber, A. O., Sutherland, D. E. R., Merion, R. M., Gruber, S. A., Schweitzer, E., Leone, J. P., Marsh, C. L., Alfrey, E., Concepcion, W., Stegall, M. D., Schulak, J. A., Gores, P. F., Benedetti, E., Smith, C., Henning, A. K., ... Fitzsimmons, W. E. (2003). Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation. American Journal of Transplantation, 3(7), 855-864. https://doi.org/10.1034/j.1600-6143.2003.00160.x