title: A prospective 3-yr evaluation of tacrolimus-based immunosuppressive therapy in immunological high risk renal allograft recipients.
abstract: BACKGROUND
  There have been no published data on use of the the newer immunosuppressants tacrolimus and mycophenolate mofetil (MMF) in high immunological risk renal transplantation. We therefore undertook a prospective study to systematically assess outcomes using these agents as part of an aggressive immunosuppressive regimen.
  
  
  METHODS
  Fifty-nine high-risk renal allograft recipients were enrolled at 10 Canadian sites and given a regimen of: a biological induction agent, tacrolimus, MMF, and corticosteroids. Patients included 10 (17%) who had lost a previous graft to rejection <1 yr, 31 (53%) with a current panel reactive antibody (PRA) >30%, 47 (80%) with a historic PRA >50%, four (7%) who had a positive historical T-cell crossmatch with the current donor, and six (10%) with a current positive B-cell crossmatch. The mean peak PRA was 76 +/- 33%.
  
  
  RESULTS
  The estimated 3-yr Kaplan-Meier patient and graft survival estimates were 89% and 75%, respectively. There were nine graft losses other than deaths with a functioning graft, of which six were preceded by delayed graft function (p = 0.01, chi2). Sixteen (27%) recipients experienced at least one episode of biopsy-confirmed acute rejection. Infections included cytomegalovirus in 16 patients, eight of whom had tissue-invasive disease. Only one malignancy occurred.
  
  
  CONCLUSIONS
  The immunosuppressive strategy investigated is effective and displays a satisfactory safety profile in high immunological risk renal allograft recipients.
authors.affiliation: St Michael's Hospital, Toronto, Ontario, Canada. jerey.zaltzman@utoronto.ca
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Zaltzman
authors.forename: Anne
authors.initials: A
authors.lastname: Boucher
authors.forename: Stephan
authors.initials: S
authors.lastname: Busque
authors.forename: Phillip F
authors.initials: PF
authors.lastname: Halloran
authors.forename: David N
authors.initials: DN
authors.lastname: Landsberg
authors.forename: Vivian C
authors.initials: VC
authors.lastname: McAlister
authors.forename: David
authors.initials: D
authors.lastname: Russell
authors.forename: Ahmed
authors.initials: A
authors.lastname: Shoker
authors.forename: Jean
authors.initials: J
authors.lastname: Shapiro
authors.forename: Jean I
authors.initials: JI
authors.lastname: Tchervenkov
authors.forename: Ralph
authors.initials: R
authors.lastname: Ferguson
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006084:Graft Rejection / Q000276:immunology; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000276:immunology / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016019:Survival Analysis; D016559:Tacrolimus / Q000276:immunology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus