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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).

american journal of transplantation

Safety and efficacy of eculizumab in the prevention of antibody‐mediated rejection in living‐donor kidney transplant recipients requiring desensitization therapy: A randomized trial