Eculizumab in antibody-mediated rejection in DD kidney transplant

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, SINGLE-ARM, MULTICENTER TRIAL TO DETERMINE SAFETY AND EFFICACY OF ECULIZUMAB IN THE PREVENTION OF ANTIBODY MEDIATED REJECTION (AMR) IN SENSITIZED RECIPIENTS OF A KIDNEY TRANSPLANT FROM A DECEASED DONOR

• IRAS ID

  98818

• Contact name

  Nicholas Torpey

• Sponsor organisation

  Alexion Pharmaceuticals, Inc.

• Eudract number

  2010-019631-35

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Over 25% of kidney transplant candidates have antibodies (are sensitised) to potential organ donors. As a result, Antibody Mediated Rejection (AMR) has emerged as a significant problem. Currently, the options to prevent AMR are limited and marginally successful. No products are approved for the treatment of AMR. Eculizumab, an inhibitor of C5, has been shown in hypothesis generating studies to successfully reduce the incidence of AMR following kidney transplantation of sensitised recipients. This phase II study is designed to assess the effect of eculizumab on the incidence of AMR in recipients who receive kidney allografts from deceased donors to whom they are sensitised. This is an open-label trial that means every participant will receive eculizumab The study will take place in approximately 20 kidney transplant centres in North America, Europe, and Australia. The protocol requires that patients remain in the study for 3 years, from enrolling to completion of follow up.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  12/EE/0092

• Date of REC Opinion

  2 May 2012

• REC opinion

  Further Information Favourable Opinion