A controlled, open-label post-authorisation efficacy and safety study in imlifidase desensitised kidney transplant patients with positive crossmatch against a deceased donor prior to imlifidase treatment, including non-comparative registry and concurrent reference cohorts

This study is exploring a new way to help people who have severe kidney disease and are on the waiting list for a kidney transplant. When someone needs a new kidney, their body's immune system can sometimes be very sensitive to the donor's kidney. This is called being 'highly sensitised', and it can make it much harder to find a suitable kidney and successfully complete a transplant.

The new medicine being tested, called Idefirix, is designed to reduce these strong reactions, making it more likely that a person can receive a compatible kidney. The main goal of this study is to see if patients who receive Idefirix can get a transplant and if their new kidney continues to work well for at least one year. This is really important because it could mean more people get the life-changing kidney transplant they need.

Researchers will also be carefully monitoring many other things. They will check how well the new kidney is working at different times, if patients stay healthy after the transplant, and if the medicine generally helps prepare the body for the new kidney. They will also look at any side effects to make sure the treatment is safe.