2019
DOI: 10.1111/ajt.15364
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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

Abstract: 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 (NCT01399593). 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 co… Show more

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Cited by 114 publications
(110 citation statements)
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“…of death or date of graft loss. Importantly, no grafts were lost to acute AMR in the early posttransplant period, which adds support to the observations that, despite activation of the classical complement pathway, eculizumab may limit the clinical consequences of acute AMR soon after transplant 26,30. After 36 months, patient survival was 91.5%, and graft survival was 83.4% Days of serum creatinine >30% above nadir b after acute AMR diagnosis, N = 2 AMR, antibody-mediated rejection.…”
supporting
confidence: 67%
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“…of death or date of graft loss. Importantly, no grafts were lost to acute AMR in the early posttransplant period, which adds support to the observations that, despite activation of the classical complement pathway, eculizumab may limit the clinical consequences of acute AMR soon after transplant 26,30. After 36 months, patient survival was 91.5%, and graft survival was 83.4% Days of serum creatinine >30% above nadir b after acute AMR diagnosis, N = 2 AMR, antibody-mediated rejection.…”
supporting
confidence: 67%
“…30 Graft loss was a significant contributor to the outcome of this study. As expected, the incidence of AMR decreased after the first 9 weeks.…”
Section: Discussionmentioning
confidence: 85%
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“…The incidence of AMR was 7.7% (2/26) in the eculizumab group compared to 41.2% (21/51) in the control group. This was the basis of a phase 2 randomized evaluate the safety and efficacy of eculizumab in preventing acute AMR in kidney transplant recipients who required desensitization . One hundred and two patients underwent desensitization.…”
Section: Desensitization Treatmentsmentioning
confidence: 99%
“…The reported prevalence is similar to that observed in standard transplant recipients. In the phase 2, randomized, study evaluating the safety and efficacy of eculizumab in preventing acute AMR in sensitized recipients of living donor kidney transplants requiring pretransplant desensitization, infections rates were 62.7% in the treatment group and 49% in the SOC group over the 28 month study period . Interpreting long‐term risks from the above‐mentioned short‐term studies is not possible.…”
Section: Long‐term Risks Of Desensitizationmentioning
confidence: 99%