A PAES study in imlifidase desensitised kidney transplant patients
Research type
Research Study
Full title
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
IRAS ID
1004426
Contact name
Krystle Villanueva
Contact email
Sponsor organisation
Hansa Biopharma AB
Eudract number
2021-002640-70
Clinicaltrials.gov Identifier
Research summary
This study in highly sensitised kidney transplant participants with a high degree of antibodies against the donor's kidney will investigate the effectiveness and safety of imlifidase to temporarily remove the antibodies and enable the transplantation. The role of antibodies is to protect against infections keeping a person healthy. Out of all participants who undergo or are listed for kidney transplantation annually, 20% to 30% of participants have antibodies to such a high degree that transplantation can be delayed or not performed at all, because the level of antibodies may lead to a rejection of the implanted kidney.
Group 1 will enrol participants who are waiting for a kidney transplant with a high degree of antibodies against the donor’s kidney. These participants will receive one or two doses of imlifidase by intravenous injection prior to the transplant. The total study duration will not exceed 15 months and consist of 13 visits. The first two visits will take place prior to transplantation. Visit 3-9 will take place while the participant is hospitalised following transplantation. Visits 10-13 will be conducted to follow up participants after discharge from hospital and will normally coincide with routine clinic visits.
Group 2 will enrol participants who are waiting for a kidney transplant without antibodies who will be transplanted and treated in accordance with their local hospital standard of care. The total duration will not exceed 12 months and consist of 5 visits.
Group 3 is a historical reference group without antibodies will be selected from the Collaborative Transplant Study registry.
Imlifidase has conditional approval from the European & UK Health Agency, which is based on studies of a total of 46 persons being treated with imlifidase and successfully transplanted. The purpose of this study is to further investigate the effectiveness and safety of imlifidase and will take place at 3 NHS hospitals which specialise in kidney transplant surgery.REC name
London - Chelsea Research Ethics Committee
REC reference
22/LO/0023
Date of REC Opinion
8 Feb 2022
REC opinion
Further Information Favourable Opinion