Document Detail

Reduction of acute renal allograft rejection by daclizumab. Daclizumab Double Therapy Study Group.
MedLine Citation:
PMID:  9921806     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Acute rejection is still a major problem in renal transplantation and is one of the most important causes of chronic graft dysfunction and late graft loss. Selective immunosuppression with a humanized antibody against the alpha-chain of the interleukin (IL)-2 receptor (CD25) was evaluated to demonstrate the efficacy of this type of immunoprophylaxis in combination with dual immunosuppression. METHODS: We studied the effect of daclizumab, a humanized monoclonal antibody against the alpha-chain of the IL-2 receptor, in a randomized double-blind, prospective phase III clinical trial in 275 patients receiving a first cadaveric renal allograft. Among them 111 (83%) in the placebo arm and 116 (82%) in the daclizumab arm received the full regimen of five doses (1.0 mg/kg) every other week. Baseline immunosuppression consisted of cyclosporine and corticosteroids. RESULTS: At 6 months, 39 (28%) of the patients in the daclizumab group had biopsy-proven rejections, as compared with 63 (47%) in the placebo group (P=0.001). The need for additional antilymphocyte therapy, antithymocyte globulin, antilymphocyte globulin (ATG, ALG, OKT3) was also lower in the daclizumab group (8% vs. 16%, P=0.02), and they required significantly lower mean (+/- SD) cumulative doses of prednisone (3750+/-1981 mg vs. 4438+/-2667 mg in the placebo group, P=0.01). Graft function was significantly better (P=0.02) in the daclizumab group (graft function rate: 58 vs. 51 ml/min, mean) as was patient survival (P=0.01, 99% vs. 94%). No specific adverse events were observed in daclizumab-treated patients. Patients receiving daclizumab experienced fewer cytomegalovirus infections (18% vs. 25%), and none died from severe infectious complications, compared to four patients in the placebo arm. No patient in the daclizumab group had a lymphoproliferative disorder or any other form of immunosuppression-related tumor during the first year after transplant. CONCLUSIONS: Administration of daclizumab in addition to dual immunosuppression therapy significantly reduced biopsy-proven acute rejection after renal transplantation, improved patient survival, and did not add to the toxicity of the immunosuppressive regimen.
B Nashan; S Light; I R Hardie; A Lin; J R Johnson
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Transplantation     Volume:  67     ISSN:  0041-1337     ISO Abbreviation:  Transplantation     Publication Date:  1999 Jan 
Date Detail:
Created Date:  1999-02-22     Completed Date:  1999-02-22     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0132144     Medline TA:  Transplantation     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  110-5     Citation Subset:  IM    
Klinik für Abdominal- und Transplantationschirurgie, Medizinische Hochschule Hannover, Germany.
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MeSH Terms
Adrenal Cortex Hormones / therapeutic use
Antibodies, Monoclonal / administration & dosage,  adverse effects,  therapeutic use*
Cyclosporine / therapeutic use
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Graft Rejection / prevention & control*
Immunoglobulin G / administration & dosage,  adverse effects,  therapeutic use*
Immunosuppressive Agents / administration & dosage,  adverse effects,  therapeutic use*
Infection / chemically induced
Kidney Transplantation*
Middle Aged
Prospective Studies
Transplantation, Homologous
Reg. No./Substance:
0/Adrenal Cortex Hormones; 0/Antibodies, Monoclonal; 0/Immunoglobulin G; 0/Immunosuppressive Agents; 152923-56-3/daclizumab; 59865-13-3/Cyclosporine

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