title: A randomized trial of thymoglobulin vs. alemtuzumab (with lower dose maintenance immunosuppression) vs. daclizumab in renal transplantation at 24 months of follow-up.
abstract: BACKGROUND
  A long-term prospective randomized trial evaluating alemtuzumab, a humanized anti-CD52 monoclonal antibody, in a predominantly non-Caucasian population has yet to be reported.
  
  
  METHODS
  Ninety deceased donor (DD) first renal transplant recipients were randomized into three different antibody induction groups: group A, thymoglobulin (Thymo); group B, alemtuzumab; group C, daclizumab (Dac). In groups A and C, the target trough levels of tacrolimus were 8-10 ng/mL, mycophenolate mofetil (MMF) 1 g administered twice daily, and maintenance methylprednisolone. In group B, target tacrolimus trough levels were 4-7 ng/mL, 500 mg MMF administered twice-daily, without methylprednisolone. African-Americans and Hispanics comprised more than 50% in each group.
  
  
  RESULTS
  A minimum follow-up of 27 months showed no overall group differences in patient or graft survival (p = 0.89 and 0.66), but a trend towards worse death-censored graft survival in group B (p = 0.05). Acute rejection rates were not significantly different: six (20%), seven (23%), and seven (23%) in groups A, B, and C, respectively. The incidence of chronic allograft nephropathy was higher in group B than in A and C (p = 0.008). The mean calculated creatinine clearance at 24 months was 81.1 +/- 5.5, 64.4 +/- 4.5, and 80.7 +/- 5.7 in groups A, B, and C, respectively (p = 0.01 for B vs. average of A and C).
  
  
  CONCLUSIONS
  In this randomized 27-month minimum follow-up trial of predominantly non-Caucasian DD renal transplant recipients with alemtuzumab induction, lower maintenance tacrolimus, MMF, and steroid avoidance appear less effective than either Thymo or Dac with higher maintenance immunosuppression.
authors.affiliation: Department of Surgery, The Lillian Jean Kaplan Renal Transplant Center of the Division of Transplantation, University of Miami Leonard M. Miller School of Medicine, Miami, FL 33101, USA. gciancio@med.miami.edu
authors.forename: Gaetano
authors.initials: G
authors.lastname: Ciancio
authors.forename: George W
authors.initials: GW
authors.lastname: Burke
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Gaynor
authors.forename: David
authors.initials: D
authors.lastname: Roth
authors.forename: Warren
authors.initials: W
authors.lastname: Kupin
authors.forename: Anne
authors.initials: A
authors.lastname: Rosen
authors.forename: Tatiana
authors.initials: T
authors.lastname: Cordovilla
authors.forename: Lissett
authors.initials: L
authors.lastname: Tueros
authors.forename: Eva
authors.initials: E
authors.lastname: Herrada
authors.forename: Joshua
authors.initials: J
authors.lastname: Miller
mesh_terms: D000328:Adult; D001741:Black or African American; D000368:Aged; D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000008:administration & dosage*; D000961:Antilymphocyte Serum; D000077561:Daclizumab; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control*; D006085:Graft Survival; D006630:Hispanic or Latino; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D053208:Kaplan-Meier Estimate; D016030:Kidney Transplantation / Q000276:immunology / Q000379:methods*; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D016559:Tacrolimus / Q000627:therapeutic use; D014184:Transplantation, Homologous; D044465:White People
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D000961:Antilymphocyte Serum; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D000074323:Alemtuzumab; D000077561:Daclizumab; C512542:thymoglobulin; D009173:Mycophenolic Acid; D016559:Tacrolimus; D008775:Methylprednisolone