title: Kidney transplantation with minimized maintenance: alemtuzumab induction with tacrolimus monotherapy--an open label, randomized trial.
abstract: BACKGROUND
  Immunosuppressive regimens for kidney transplantation which reduce the long-term burden of immunosuppression are attractive, but little data are available to judge the safety and efficacy of the different strategies used. We tested the hypothesis that the simple, cheap, regimen of alemtuzumab induction combined with tacrolimus monotherapy maintenance provided equivalent outcomes to the more commonly used combination of interleukin-2 receptor monoclonal antibody induction with tacrolimus and mycophenolate mofetil combination maintenance, both regimens using steroid withdrawal after 7 days.
  
  
  METHODS
  One hundred twenty-three live or deceased donor renal transplant recipients were randomized 2:1 to receive alemtuzumab/tacrolimus or daclizumab/tacrolimus/mycophenolate. The primary endpoint was survival with a functioning graft at 1 year.
  
  
  RESULTS
  Both regimens produced equivalent, excellent outcomes with the primary outcome measure of 97.6% in the alemtuzumab arm and 95.1% in the daclizumab arm at 1 year (95% confidence interval of difference 6.9% to -1.7%) and at 2 years 92.6% and 95.1%. Rejection was less frequent in the alemtuzumab arm with 1- and 2-year rejection-free survival of 91.2% and 89.9% compared with 82.3% and 82.3% in the daclizumab arm. There were no significant differences in terms of the occurrence of opportunistic infections.
  
  
  CONCLUSIONS
  Alemtuzumab induction with tacrolimus maintenance monotherapy and short-course steroid use provides a simple, safe, and effective immunosuppressive regimen for renal transplantation.
authors.affiliation: Imperial College Kidney & Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, UK.
authors.forename: Kakit
authors.initials: K
authors.lastname: Chan
authors.forename: David
authors.initials: D
authors.lastname: Taube
authors.forename: Candice
authors.initials: C
authors.lastname: Roufosse
authors.forename: Terence
authors.initials: T
authors.lastname: Cook
authors.forename: Paul
authors.initials: P
authors.lastname: Brookes
authors.forename: Dawn
authors.initials: D
authors.lastname: Goodall
authors.forename: Jack
authors.initials: J
authors.lastname: Galliford
authors.forename: Tom
authors.initials: T
authors.lastname: Cairns
authors.forename: Anthony
authors.initials: A
authors.lastname: Dorling
authors.forename: Neill
authors.initials: N
authors.lastname: Duncan
authors.forename: Nadey
authors.initials: N
authors.lastname: Hakim
authors.forename: Andrew
authors.initials: A
authors.lastname: Palmer
authors.forename: Vassilios
authors.initials: V
authors.lastname: Papalois
authors.forename: Anthony N
authors.initials: AN
authors.lastname: Warrens
authors.forename: Michelle
authors.initials: M
authors.lastname: Willicombe
authors.forename: Adam G
authors.initials: AG
authors.lastname: McLean
mesh_terms: D000328:Adult; D000074323:Alemtuzumab; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D000912:Antibodies, Neoplasm / Q000009:adverse effects / Q000627:therapeutic use*; D000077561:Daclizumab; D004359:Drug Therapy, Combination; D005260:Female; D006085:Graft Survival / Q000276:immunology / Q000502:physiology; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology* / Q000502:physiology; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D011446:Prospective Studies; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D000074323:Alemtuzumab; D000077561:Daclizumab; D009173:Mycophenolic Acid; D016559:Tacrolimus