title: Prospective, randomized, multi-center trial of antibody induction therapy in simultaneous pancreas-kidney transplantation.
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.
authors.affiliation: Feinberg School of Medicine at Northwestern University, Chicago, IL, USA. d-kaufman2@northwestern.edu
authors.forename: Dixon B
authors.initials: DB
authors.lastname: Kaufman
authors.forename: George W
authors.initials: GW
authors.lastname: Burke
authors.forename: David S
authors.initials: DS
authors.lastname: Bruce
authors.forename: Christopher P
authors.initials: CP
authors.lastname: Johnson
authors.forename: A Osama
authors.initials: AO
authors.lastname: Gaber
authors.forename: David E R
authors.initials: DE
authors.lastname: Sutherland
authors.forename: Robert M
authors.initials: RM
authors.lastname: Merion
authors.forename: Scott A
authors.initials: SA
authors.lastname: Gruber
authors.forename: Eugene
authors.initials: E
authors.lastname: Schweitzer
authors.forename: John P
authors.initials: JP
authors.lastname: Leone
authors.forename: Christopher L
authors.initials: CL
authors.lastname: Marsh
authors.forename: Edward
authors.initials: E
authors.lastname: Alfrey
authors.forename: Waldo
authors.initials: W
authors.lastname: Concepcion
authors.forename: Mark D
authors.initials: MD
authors.lastname: Stegall
authors.forename: James A
authors.initials: JA
authors.lastname: Schulak
authors.forename: Paul F
authors.initials: PF
authors.lastname: Gores
authors.forename: Enrico
authors.initials: E
authors.lastname: Benedetti
authors.forename: Craig
authors.initials: C
authors.lastname: Smith
authors.forename: Alice K
authors.initials: AK
authors.lastname: Henning
authors.forename: Fernando
authors.initials: F
authors.lastname: Kuehnel
authors.forename: Sarah
authors.initials: S
authors.lastname: King
authors.forename: William E
authors.initials: WE
authors.lastname: Fitzsimmons
mesh_terms: D000906:Antibodies / Q000494:pharmacology*; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007116:Immunization, Passive / Q000379:methods*; D007166:Immunosuppressive Agents / Q000494:pharmacology*; D016030:Kidney Transplantation; D008214:Lymphocytes / Q000276:immunology; D016035:Pancreas Transplantation
chemical_list: D000906:Antibodies; D007166:Immunosuppressive Agents