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Safety and efficacy of eculizumab in the prevention of antibody‐mediated rejection in living‐donor kidney transplant recipients requiring desensitization therapy: A randomized trial
Author(s) -
Marks William H.,
Mamode Nizam,
Montgomery Robert A.,
Stegall Mark D.,
Ratner Lloyd E.,
Cornell Lynn D.,
Rowshani Ajda T.,
Colvin Robert B.,
Dain Bradley,
Boice Judith A.,
Glotz Denis
Publication year - 2019
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.15364
Subject(s) - medicine , eculizumab , desensitization (medicine) , randomized controlled trial , clinical endpoint , clinical trial , kidney transplantation , kidney , surgery , gastroenterology , immunology , complement system , antibody , receptor
We report results of a phase 2, randomized, multicenter, open‐label, two‐arm study evaluating the safety and efficacy of eculizumab in preventing acute antibody‐mediated rejection ( AMR ) in sensitized recipients of living‐donor kidney transplants requiring pretransplant desensitization ( NCT 01399593). In total, 102 patients underwent desensitization. Posttransplant, 51 patients received standard of care ( SOC ) and 51 received eculizumab. The primary end point was week 9 posttransplant treatment failure rate, a composite of: biopsy‐proven acute AMR (Banff 2007 grade II or III ; assessed by blinded central pathology); graft loss; death; or loss to follow‐up. Eculizumab was well tolerated with no new safety concerns. No significant difference in treatment failure rate was observed between eculizumab (9.8%) and SOC (13.7%; P = .760). To determine whether data assessment assumptions affected study outcome, biopsies were reanalyzed by central pathologists using clinical information. The resulting treatment failure rates were 11.8% and 21.6% for the eculizumab and SOC groups, respectively (nominal P = .288). When reassessment included grade I AMR , the treatment failure rates were 11.8% (eculizumab) and 29.4% ( SOC ; nominal P = .048). This finding suggests a potential benefit for eculizumab compared with SOC in preventing acute AMR in recipients sensitized to their living‐donor kidney transplants (Eudra CT 2010‐019630‐28).