Document Detail

Randomized trial of dual antibody induction therapy with steroid avoidance in renal transplantation.
MedLine Citation:
PMID:  22027927     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Given our previous experience using dual-induction therapy with antithymocyte globulin (ATG)/daclizumab (Dac) (each with fewer doses than if used alone), we chose to compare two distinct dual-induction strategies.
METHODS: Single-center, open-label randomized trial of 200 primary kidney transplant recipients was performed: (group I, n=100) ATG/Dac (3 ATG, 2 Dac doses) versus (group II, n=100) ATG/alemtuzumab (1 dose each), with maintenance consisting of reduced tacrolimus dosing (rTd), enteric-coated mycophenolate sodium (EC-MPS), and early corticosteroid withdrawal. One half of standard EC-MPS dosing was targeted in group II to avoid severe leukopenia previously seen with alemtuzumab. The goal in both arms was to achieve rapid and effective lymphocyte depletion while simultaneously allowing reduced maintenance immunosuppression. Primary endpoint was the incidence of biopsy-proven acute rejection (BPAR).
RESULTS: With median follow-up of 38 months, there were no differences in BPAR rates: 14 of 100 vs. 13 of 100 (including borderline) and 10 of 100 vs. 9 of 100 (excluding borderline) in groups I and II, respectively (nonsignificant). Actuarial patient/graft survival at 48 months was 96%/91% in group I vs. 92%/83% in group II (N.S.). Mean estimated glomerular filtration rate (±standard error) at 36 months was 72.1±3.3 vs. 67.5±3.3 in groups I and II (N.S.). Greater incidence of leukopenia occurred in group II at month 1 only (P=0.002). Percentages having EC-MPS withheld/discontinued due to leukopenia, gastrointestinal symptoms, and infection were 12 of 100, 7 of 100, and 0 of 100 in group I vs. 19 of 100, 0 of 100, and 2 of 100 in group II, respectively (P=0.01). Rates of new onset diabetes mellitus after transplantation and infections were equally low in both groups (no lymphoproliferative disorders were observed).
CONCLUSIONS: These two distinct dual-induction therapies with rTd, EC-MPS, and planned early corticosteroid withdrawal resulted in favorable rates of BPAR and all secondary outcomes.
Gaetano Ciancio; Jeffrey J Gaynor; Junichiro Sageshima; Giselle Guerra; Alberto Zarak; David Roth; Randolph Brown; Warren Kupin; Linda Chen; Lois Hanson; Lissett Tueros; Phillip Ruiz; Alan S Livingstone; George W Burke
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Transplantation     Volume:  92     ISSN:  1534-6080     ISO Abbreviation:  Transplantation     Publication Date:  2011 Dec 
Date Detail:
Created Date:  2011-12-14     Completed Date:  2012-03-20     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  0132144     Medline TA:  Transplantation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1348-57     Citation Subset:  IM    
Department of Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.
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MeSH Terms
Adrenal Cortex Hormones / administration & dosage
Antibodies, Monoclonal, Humanized / administration & dosage*
Antibodies, Neoplasm / administration & dosage*
Antilymphocyte Serum / administration & dosage*
Follow-Up Studies
Graft Rejection / immunology,  prevention & control*
Immunoglobulin G / administration & dosage*
Immunosuppressive Agents / administration & dosage
Kidney Transplantation*
Tacrolimus / administration & dosage
Treatment Outcome
Reg. No./Substance:
0/Adrenal Cortex Hormones; 0/Antibodies, Monoclonal, Humanized; 0/Antibodies, Neoplasm; 0/Antilymphocyte Serum; 0/Immunoglobulin G; 0/Immunosuppressive Agents; 109581-93-3/Tacrolimus; 3A189DH42V/alemtuzumab; CUJ2MVI71Y/daclizumab

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