title: Randomized trial of single-dose versus divided-dose rabbit anti-thymocyte globulin induction in renal transplantation: an interim report.
abstract: BACKGROUND
  The optimal dosing protocol for rabbit anti-thymocyte globulin (rATG) induction in renal transplantation has not been determined, but evidence exists that rATG infusion before renal allograft reperfusion improves early graft function. Infusing a large rATG dose over a short interval has not previously been evaluated for its effect on renal function and allograft nephropathy in a prospective, randomized comparison against conventional rATG induction.
  
  
  METHODS
  Between April 20, 2004 and December 26, 2007 we enrolled renal transplant patients into a prospective, randomized, nonblinded trial of two rATG dosing protocols (single dose, 6 mg/kg vs. divided doses, 1.5 mg/kg every other day x 4; target enrollment=160) followed after 6 months by calcineurin-inhibitor withdrawal. Primary endpoints are renal function by calculated glomerular filtration rate (GFR) and chronic allograft nephropathy at protocol biopsy. We now present the early GFR data of all 160 patients and safety and efficacy data of the first 142 patients with 6 months follow up and before calcineurin inhibitor withdrawal (average follow up=23.3+/-11.6 months).
  
  
  RESULTS
  There were no differences between groups in rATG-related adverse events, patient and graft survival, acute rejection, or chronic allograft nephropathy rate at 6 months. Calculated DeltaGFR (POD 1-4) was significantly better in the single-dose group (P=0.02), with a trend toward improved renal function from months 2 to 6 in recipients of deceased donor kidneys (P=0.08).
  
  
  CONCLUSIONS
  This study demonstrates that administering 6 mg/kg of rATG over 24 hr is safe and is associated with improved early renal function compared with administering rATG in alternate-day doses.
authors.affiliation: Department of Surgery, University of Nebraska Medical Center, Omaha, NE 68198-3285, USA. rbstevens@unmc.edu
authors.forename: R Brian
authors.initials: RB
authors.lastname: Stevens
authors.forename: David F
authors.initials: DF
authors.lastname: Mercer
authors.forename: Wendy J
authors.initials: WJ
authors.lastname: Grant
authors.forename: Alison G
authors.initials: AG
authors.lastname: Freifeld
authors.forename: James T
authors.initials: JT
authors.lastname: Lane
authors.forename: Gerald C
authors.initials: GC
authors.lastname: Groggel
authors.forename: Theodore H
authors.initials: TH
authors.lastname: Rigley
authors.forename: Kathleen J
authors.initials: KJ
authors.lastname: Nielsen
authors.forename: Megan E
authors.initials: ME
authors.lastname: Henning
authors.forename: Jill Y
authors.initials: JY
authors.lastname: Skorupa
authors.forename: Anna J
authors.initials: AJ
authors.lastname: Skorupa
authors.forename: Kecia A
authors.initials: KA
authors.lastname: Christensen
authors.forename: John P
authors.initials: JP
authors.lastname: Sandoz
authors.forename: Anna M
authors.initials: AM
authors.lastname: Kellogg
authors.forename: Alan N
authors.initials: AN
authors.lastname: Langnas
authors.forename: Lucile E
authors.initials: LE
authors.lastname: Wrenshall
mesh_terms: D000328:Adult; D000818:Animals; D000961:Antilymphocyte Serum / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000379:methods; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D016030:Kidney Transplantation / Q000009:adverse effects / Q000276:immunology* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011817:Rabbits; D020123:Sirolimus / Q000627:therapeutic use; D016019:Survival Analysis; D016559:Tacrolimus / Q000627:therapeutic use; D014184:Transplantation, Homologous
chemical_list: D000961:Antilymphocyte Serum; D020123:Sirolimus; D016559:Tacrolimus