title: Randomized trial of thymoglobulin versus alemtuzumab (with lower dose maintenance immunosuppression) versus daclizumab in living donor renal transplantation.
abstract: BACKGROUND
  We performed a randomized trial evaluating alemtuzumab, a humanized anti-CD52 monoclonal antibody, in living donor (LD) kidney transplantation.
  
  
  METHODS
  Thirty-eight LD first renal transplant recipients were randomized into three single-agent antibody induction groups: thymoglobulin (group A); alemtuzumab (group B); and daclizumab (group C). In groups A and C, target tacrolimus trough levels were 6 to 8 ng/mL, with 1 gm mycophenolate mofetil (MMF) administered twice daily, and maintenance methylprednisolone. In group B, the target tacrolimus trough level was 4 to 6 ng/mL, with 500 mg MMF administered twice daily, without methylprednisolone.
  
  
  RESULTS
  With 29/38 patients now followed beyond 36 months posttransplantation, we observed no graft failures and only one death with a functioning graft (in group B). Acute rejection episodes were low: 0/13, 1/13, and 1/12 patients in groups A, B, and C. Biopsy-proven chronic allograft injury was higher among group B (3/13) versus groups A (0/13) or C (0/12; P = .01). Poorer renal function was observed in group B; the mean calculated creatinine clearance at 3 months posttransplantation was significantly poorer: 63.3 ± 3.0 versus 85.4 ± 7.2 and 82.2 ± 8.2 in groups A and C (P = .01). No differences in the incidence of adverse events were observed.
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, Florida, USA.
authors.forename: G
authors.initials: G
authors.lastname: Ciancio
authors.forename: J J
authors.initials: JJ
authors.lastname: Gaynor
authors.forename: D
authors.initials: D
authors.lastname: Roth
authors.forename: W
authors.initials: W
authors.lastname: Kupin
authors.forename: L
authors.initials: L
authors.lastname: Hanson
authors.forename: L
authors.initials: L
authors.lastname: Tueros
authors.forename: A
authors.initials: A
authors.lastname: Zarak
authors.forename: P
authors.initials: P
authors.lastname: Ruiz
authors.forename: G W
authors.initials: GW
authors.lastname: Burke
mesh_terms: D000328:Adult; D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000008:administration & dosage*; D000961:Antilymphocyte Serum; D015415:Biomarkers / Q000097:blood; D001706:Biopsy; D016009:Chi-Square Distribution; D003404:Creatinine / Q000097:blood; D000077561:Daclizumab; D004359:Drug Therapy, Combination; D005260:Female; D005431:Florida; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage*; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D053208:Kaplan-Meier Estimate; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013256:Steroids / Q000008:administration & dosage; D016559:Tacrolimus / Q000008:administration & dosage; D013997:Time Factors; D014184:Transplantation, Homologous; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D000961:Antilymphocyte Serum; D015415:Biomarkers; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D013256:Steroids; D000074323:Alemtuzumab; D003404:Creatinine; D000077561:Daclizumab; C512542:thymoglobulin; D009173:Mycophenolic Acid; D016559:Tacrolimus