Eculizumab in antibody-mediated rejection in LD kidney transplant

• Research type

  Research Study

• Full title

  A RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL TO DETERMINE SAFETY AND EFFICACY OF ECULIZUMAB IN THE PREVENTION OF ANTIBODY MEDIATED REJECTION (AMR) IN LIVING DONOR KIDNEY TRANSPLANT RECIPIENTS REQUIRING DESENSITIZATION THERAPY

• IRAS ID

  82065

• Contact name

  Jack Galliford

• Sponsor organisation

  Alexion Pharmaceuticals, Inc.

• Eudract number

  2010-019630-28

• ISRCTN Number

  no issue

• 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 living donors to whom they are sensitised and require desensitisation therapy prior to transplantation.The study will take place in approximately 20 kidney transplant centres in North America, Europe, and Australia.Each transplant centre must select a desensitisation protocol as their standard of care (this will form the control group for comparison to the eculizumab group). The protocol requires that patients remain in the study for 3 years, from enrolling to completion of follow up.Patients will have a 1 in 2 chance of being randomised to either the eculizumab or the standard treatment group.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  11/LO/1164

• Date of REC Opinion

  19 Oct 2011

• REC opinion

  Further Information Favourable Opinion