Safety and efficacy of eculizumab for the prevention of antibody-mediated rejection after deceased-donor kidney transplantation in patients with preformed donor-specific antibodies

Am J Transplant. 2019 Oct;19(10):2865-2875. doi: 10.1111/ajt.15397. Epub 2019 May 24.


The presence of preformed donor-specific antibodies in transplant recipients increases the risk of acute antibody-mediated rejection (AMR). Results of an open-label single-arm trial to evaluate the safety and efficacy of eculizumab in preventing acute AMR in recipients of deceased-donor kidney transplants with preformed donor-specific antibodies are reported. Participants received eculizumab as follows: 1200 mg immediately before reperfusion; 900 mg on posttransplant days 1, 7, 14, 21, and 28; and 1200 mg at weeks 5, 7, and 9. All patients received thymoglobulin induction therapy and standard maintenance immunosuppression including steroids. The primary end point was treatment failure rate, a composite of biopsy-proved grade II/III AMR (Banff 2007 criteria), graft loss, death, or loss to follow-up, within 9 weeks posttransplant. Eighty patients received transplants (48 women); the median age was 52 years (range 24-70 years). Observed treatment failure rate (8.8%) was significantly lower than expected for standard care (40%; P < .001). By 9 weeks, 3 of 80 patients had experienced AMR, and 4 of 80 had experienced graft loss. At 36 months, graft and patient survival rates were 83.4% and 91.5%, respectively. Eculizumab was well tolerated and no new safety concerns were identified. Eculizumab has the potential to provide prophylaxis against injury caused by acute AMR in such patients (EudraCT 2010-019631-35).

Keywords: clinical research/practice; complement biology; donors and donation: deceased; immunosuppressant-fusion proteins and monoclonal antibodies; kidney transplantation/nephrology; rejection: antibody-mediated (ABMR); sensitization.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Complement Inactivating Agents / therapeutic use*
  • Female
  • Follow-Up Studies
  • Graft Rejection / drug therapy*
  • Graft Rejection / etiology
  • Graft Rejection / pathology
  • Graft Survival / drug effects*
  • Graft Survival / immunology
  • Humans
  • Isoantibodies / adverse effects*
  • Kidney Failure, Chronic / immunology
  • Kidney Failure, Chronic / mortality*
  • Kidney Failure, Chronic / therapy
  • Kidney Transplantation / adverse effects*
  • Male
  • Middle Aged
  • Patient Safety
  • Prognosis
  • Risk Factors
  • Survival Rate
  • Tissue Donors / supply & distribution
  • Young Adult


  • Antibodies, Monoclonal, Humanized
  • Complement Inactivating Agents
  • Isoantibodies
  • eculizumab