title: ATG-Fresenius or daclizumab induction therapy in immunologically high risk kidney recipients: a prospective randomized pilot trial.
abstract: BACKGROUND
  Despite all the advantages in the immunosuppressive therapy, kidney transplantation in immunologically high risk patients remains a challenge. Ideally, an induction therapy should provide maximal graft protection, while adverse events rate and costs remain as low as possible.
  
  
  METHODS
  Immunologically high risk kidney recipients with CDC-PRA ł 25% within the last 3 years, a positive B-cell CDC-crossmatch or graft loss due to rejection within 3 years following a prior transplantation, were randomized 1:1 to receive ATG-Fresenius (ATG-F) (9 mg/kg day 0; 3 mg/kg day 1-4) or Daclizumab therapy (1 mg/kg day 0, 14, 28, 42, 56) in a pilot study. Additional immunosuppression consisted of cyclosporine, mycophenolate mofetil, and steroids. 11 patients were included in each group.
  
  
  RESULTS
  The patient (90% in ATG-F; 100% in Daclizumab) and graft survival (censored for death) (100% in ATG-F; 90% in Daclizumab) and the mean creatinine concentration at 24 months (139+/-68 mol/l in ATG-F; 176+/-103 mol/l in Daclizumab) were similar in both groups. More severe graft rejections (3 vascular rejections in Daclizumab) and adverse events (5.3/patient in ATG-F; 6.7/patient in Daclizumab) were observed in the Daclizumab group. The costs for hospitalization/ day within 24 months were lower in ATG-F (2.32+/-3.51 USD vs. 12.25+/-9.75 USD; p=0.02) resulting in an average cost-difference of more than 10'435 USD /patient.
  
  
  CONCLUSIONS
  In this pilot trial, both treatments were comparably successful regarding graft and patient outcome.
authors.affiliation: Clinic for Transplantation Immunology and Nephrology, University Hospital, Basel, Switzerland.
authors.forename: Min Jeong
authors.initials: MJ
authors.lastname: Kim
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Tsinalis
authors.forename: Stefan
authors.initials: S
authors.lastname: Franz
authors.forename: Isabelle
authors.initials: I
authors.lastname: Binet
authors.forename: Lorenz
authors.initials: L
authors.lastname: Gürke
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mihatsch
authors.forename: Jürg
authors.initials: J
authors.lastname: Steiger
authors.forename: Gilbert
authors.initials: G
authors.lastname: Thiel
authors.forename: Michael
authors.initials: M
authors.lastname: Dickenmann
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000961:Antilymphocyte Serum / Q000627:therapeutic use*; D002102:Cadaver; D003404:Creatinine / Q000097:blood; D000077561:Daclizumab; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000601:surgery*; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality / Q000502:physiology; D019520:Living Donors; D010865:Pilot Projects; D011446:Prospective Studies; D012307:Risk Factors; D012449:Safety; D016019:Survival Analysis; D017741:Survivors; D014019:Tissue Donors; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000961:Antilymphocyte Serum; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D003404:Creatinine; D000077561:Daclizumab