title: Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: results at three years.
abstract: METHODS
  Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus (TAC) + mycophenolate mofetil (MMF), TAC + azathioprine (AZA), or cyclosporine (Neoral; CsA) + MMF. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function (DGF). Patients were followed-up for 3 years.
  
  
  RESULTS
  The results at 3 years corroborate and extend the findings of the 2-year results. Patients with DGF treated with TAC+MMF experienced an increase in 3-year allograft survival compared with patients receiving CsA+MMF (84.1% vs. 49.9%, P=0.02). Patients randomized to either treatment arm containing TAC exhibited numerically superior kidney function when compared with CsA. During the 3 years, new-onset insulin dependence occurred in 6, 3, and 11 patients in the TAC+MMF, CsA+MMF, and TAC+AZA treatment arms, respectively. Furthermore, patients randomized to TAC+MMF received significantly lower doses of MMF as compared with those who received CsA+MMF.
  
  
  CONCLUSIONS
  All three immunosuppressive regimens provided excellent safety and efficacy. However, the best results overall were achieved with TAC+MMF. The combination may provide particular benefit to kidney allograft recipients with DGF. In patients who experienced DGF, graft survival was better at 3 years in those patients receiving TAC in combination with either MMF or AZA as compared with the patients receiving CsA with MMF.
authors.affiliation: Mayo Clinic Transplant Center, 4205 Belfort Blvd., Suite 1100, Jacksonville, FL, 32216, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Gonwa
authors.forename: Christopher
authors.initials: C
authors.lastname: Johnson
authors.forename: Nasimul
authors.initials: N
authors.lastname: Ahsan
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Alfrey
authors.forename: Philip
authors.initials: P
authors.lastname: Halloran
authors.forename: Mark
authors.initials: M
authors.lastname: Stegall
authors.forename: Mark
authors.initials: M
authors.lastname: Hardy
authors.forename: Robert
authors.initials: R
authors.lastname: Metzger
authors.forename: Charles
authors.initials: C
authors.lastname: Shield
authors.forename: Leslie
authors.initials: L
authors.lastname: Rocher
authors.forename: John
authors.initials: J
authors.lastname: Scandling
authors.forename: John
authors.initials: J
authors.lastname: Sorensen
authors.forename: Laura
authors.initials: L
authors.lastname: Mulloy
authors.forename: Jimmy
authors.initials: J
authors.lastname: Light
authors.forename: Claudia
authors.initials: C
authors.lastname: Corwin
authors.forename: Gabriel
authors.initials: G
authors.lastname: Danovitch
authors.forename: Michael
authors.initials: M
authors.lastname: Wachs
authors.forename: Paul
authors.initials: P
authors.lastname: VanVeldhuisen
authors.forename: Maryanne
authors.initials: M
authors.lastname: Leonhardt
authors.forename: William E
authors.initials: WE
authors.lastname: Fitzsimmons
mesh_terms: D000208:Acute Disease; D001379:Azathioprine / Q000627:therapeutic use*; D002102:Cadaver; D003404:Creatinine / Q000097:blood; D016572:Cyclosporine / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005431:Florida; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000453:epidemiology*; D006085:Graft Survival / Q000276:immunology; D006801:Humans; D006943:Hyperglycemia / Q000453:epidemiology; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality / Q000502:physiology; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000453:epidemiology; D011336:Probability; D044469:Racial Groups; D016019:Survival Analysis; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors; D014019:Tissue Donors
chemical_list: D016572:Cyclosporine; D003404:Creatinine; D009173:Mycophenolic Acid; D001379:Azathioprine; D016559:Tacrolimus