title: Effect of a single intraoperative high-dose ATG-Fresenius on delayed graft function in donation after cardiac-death donor renal allograft recipients: a randomized study.
abstract: OBJECTIVE
  Reducing the incidence of delayed graft function after transplant with donation after cardiac death donor renal allografts would facilitate managing recipients during their first weeks after a transplant. To reduce this incidence, in most studies, induction therapy with depleting anti-T-lymphocyte antibodies is coupled with a reduction of the dosage of the calcineurin inhibitor. The separate effect of anti-T-cell therapy on the incidence and duration of delayed graft function is therefore difficult to assess.
  
  
  METHODS
  We performed a randomized study to evaluate the effect of a single intraoperative high-dose of anti-T-lymphocyte immunoglobulin (ATG)-Fresenius (9 mg/kg body weight) on the incidence of delayed graft function. Eligible adult recipients of a first donation after cardiac death donor renal allograft were randomly assigned to ATG-Fresenius or no induction therapy. Maintenance immunosuppression consisted of tacrolimus, in an unadjusted dose, mycophenolate mofetil, and steroids.
  
  
  RESULTS
  The study was prematurely terminated because of a lower-than-anticipated inclusion rate. Baseline characteristics were comparable in the ATG-Fresenius group (n=28) and the control group (n=24). Twenty-two patients in the ATG-Fresenius group (79%) had delayed graft function, compared with 13 in the control group (54%; P = .06). Allograft and patient survival were comparable in both groups. Serious adverse events occurred more frequently in the ATG-Fresenius group than they did in the control group (57% vs 29%; P < .05).
  
  
  CONCLUSIONS
  Intraoperative administration of a single high-dose of ATG-Fresenius in donation after cardiac death donor renal allograft recipients, followed by triple immunosuppression with an unadjusted tacrolimus dose, seems ineffective to reduce the incidence of delayed graft function. Moreover, this was associated with a higher rate of serious adverse events (EudraCT-number, 2007-000210-36.).
authors: Department of Nephrology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. m.vandenhoogen@aig.umcn.nl
authors: Martijn W F
authors: MW
authors: van den Hoogen
authors: Marcia M L
authors: MM
authors: Kho
authors: Alferso C
authors: AC
authors: Abrahams
authors: Arjan D
authors: AD
authors: van Zuilen
authors: Jan-Stephan
authors: JS
authors: Sanders
authors: Marja
authors: M
authors: van Dijk
authors: Luuk B
authors: LB
authors: Hilbrands
authors: Willem
authors: W
authors: Weimar
authors: Andries J
authors: AJ
authors: Hoitsma
mesh_terms: D000328:Adult; D000368:Aged; D000961:Antilymphocyte Serum / Q000008:administration & dosage*; D003643:Death; D051799:Delayed Graft Function / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D015994:Incidence; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D013601:T-Lymphocytes / Q000276:immunology*; D016559:Tacrolimus / Q000008:administration & dosage; D014019:Tissue Donors; D014184:Transplantation, Homologous; D055815:Young Adult
chemical_list: D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D016559:Tacrolimus