ALXN1210-DGF-321
Research type
Research Study
Full title
A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function after Kidney Transplantation
IRAS ID
1011461
Contact name
Sanela Tarabar
Contact email
Sponsor organisation
Alexion Pharmaceuticals Inc.
Research summary
Receiving a kidney transplant from a deceased donor compared to a living donor raises the risk of delayed graft function (DGF), a medical term for when a kidney transplant does not start working right away. DGF is defined as needing at least 1 dialysis session within 1 week after transplant surgery. DGF can lead to poor kidney function or kidney rejection. The complement system is an important part of the immune system (the body’s natural defense) and appears to play an important role in developing DGF. Complement proteins, including a protein called complement component C5 (C5), cause inflammation, which injures the transplanted kidney. There are no approved therapies to treat DGF.
The medications eculizumab and ravulizumab are monoclonal antibodies produced in cells and provided for therapy as intravenous infusions. They act by blocking the activity of C5. In high-risk patients, eculizumab may reduce the severity of DGF. Ravulizumab, the study medication, works similarly to eculizumab, but is longeracting. Both medications are safe and well tolerated in adults with other conditions. The purpose of this study is to learn if ravulizumab is effective and safe in reducing the severity of DGF in people with end-stage kidney disease who are at high risk of DGF after kidney transplant.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0207
Date of REC Opinion
14 Apr 2025
REC opinion
Further Information Favourable Opinion