TY - JOUR
T1 - Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation
AU - Kaufman, Dixon B.
AU - Burke, George W.
AU - Bruce, David S.
AU - Johnson, Christopher P.
AU - Gaber, A. Osama
AU - Sutherland, David E R
AU - Merion, Robert M.
AU - Gruber, Scott A.
AU - Schweitzer, Eugene
AU - Leone, John P.
AU - Marsh, Christopher L.
AU - Alfrey, Edward
AU - Concepcion, Waldo
AU - Stegall, Mark D.
AU - Schulak, James A.
AU - Gores, Paul F.
AU - Benedetti, Enrico
AU - Smith, Craig
AU - Henning, Alice K.
AU - Kuehnel, Fernando
AU - King, Sarah
AU - Fitzsimmons, William E.
N1 - Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2003/7
Y1 - 2003/7
N2 - 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.
AB - 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.
KW - Immunosuppression
KW - Induction therapy
KW - Pancreas transplantation
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U2 - 10.1034/j.1600-6143.2003.00160.x
DO - 10.1034/j.1600-6143.2003.00160.x
M3 - Article
C2 - 12814477
AN - SCOPUS:10744221396
SN - 1600-6135
VL - 3
SP - 855
EP - 864
JO - American Journal of Transplantation
JF - American Journal of Transplantation
IS - 7
ER -