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Title
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Rabbit anti-thymocyte globulin for the prevention of acute rejection in kidney transplantation
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Author
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Abstract
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| This report describes the results of 2 international randomized trials (total of 508 kidney transplant recipients). The primary objective was to assess the noninferiority of rabbit anti-thymocyte globulin (rATG, Thymoglobulin (R)) versus interleukin-2 receptor antagonists (IL2RAs) for the quadruple endpoint (treatment failure defined as biopsy-proven acute rejection, graft loss, death, or loss to follow-up) to serve as the pivotal data for United States (US) regulatory approval of rATG. The pooled analysis provided an incidence of treatment failure of 25.1% in the rATG and 36.0% in the IL2RA treatment groups, an absolute difference of -10.9% (95% confidence interval [CI] -18.8% to -2.9%) supporting noninferiority (noninferiority margin was 10%) and superiority of rATG to IL2RA. In a meta-analysis of 7 trials comparing rATG with an IL2RA, the difference in the proportion of patients with BPAR at 12 months was -4.8% (95% CI -8.6% to -0.9%) in favor of rATG. In conclusion, a rigorous reanalysis of patient-level data from 2 prior randomized, controlled trials comparing rATG versus IL-2R monoclonal antibodies provided support for regulatory approval for rATG for induction therapy in renal transplant, making it the first T cell-depleting therapy approved for the prophylaxis of acute rejection in patients receiving a kidney transplant in the United States. |
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Language
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English
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Source (journal)
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American journal of transplantation. - Copenhagen
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Publication
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Copenhagen
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2019
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ISSN
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1600-6135
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DOI
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10.1111/AJT.15342
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Volume/pages
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19
:8
(2019)
, p. 2252-2261
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ISI
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000477056500016
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Pubmed ID
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30838775
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Full text (Publisher's DOI)
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Full text (open access)
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