title: FTY720 combined with tacrolimus in de novo renal transplantation: 1-year, multicenter, open-label randomized study.
abstract: BACKGROUND
  FTY720 (fingolimod), a novel immunomodulator, has demonstrated potential for prevention of acute rejection in combination with cyclosporine.
  
  
  METHODS
  This study evaluated FTY720 2.5 mg versus mycophenolate mofetil (MMF) in a combination regimen with standard tacrolimus and corticosteroids in de novo renal transplant recipients for the composite efficacy within 6 months of transplantation.
  
  
  RESULTS
  Incidence of treated biopsy-proven acute rejection was 22.9% with FTY720 and 18.5% with MMF. Increased incidence of macular oedema, transient decrease in heart rate and low rate of infections were seen in the FTY720 arm.
  
  
  CONCLUSIONS
  FTY720 combined with tacrolimus and steroids did not show a significant therapeutic advantage over MMF for the prevention of acute rejection in de novo renal transplant recipients.
authors.affiliation: Department of Nephrology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. a.hoitsma@nier.umcn.nl
authors.forename: Andries J
authors.initials: AJ
authors.lastname: Hoitsma
authors.forename: Ervin S
authors.initials: ES
authors.lastname: Woodle
authors.forename: Daniel
authors.initials: D
authors.lastname: Abramowicz
authors.forename: Pieter
authors.initials: P
authors.lastname: Proot
authors.forename: Yves
authors.initials: Y
authors.lastname: Vanrenterghem
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016572:Cyclosporine / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D000068876:Fingolimod Hydrochloride; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000628:therapy*; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011379:Prognosis; D011409:Propylene Glycols / Q000627:therapeutic use*; D013110:Sphingosine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015996:Survival Rate; D016559:Tacrolimus / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D011409:Propylene Glycols; D016572:Cyclosporine; D000068876:Fingolimod Hydrochloride; D009173:Mycophenolic Acid; D013110:Sphingosine; D016559:Tacrolimus