Desensitisation with imlifidase prior to kidney transplant in highly sensitised children (DINKY)
Research type
Research Study
Full title
A single-arm, multi-centre trial to evaluate efficacy and safety of imlifidase in highly sensitised children (1-17 years) receiving a kidney transplant with positive crossmatch against a living or deceased donor converted to negative after imlifidase treatment
IRAS ID
1009261
Contact name
Caroline Matthews
Contact email
Sponsor organisation
Hansa Biopharma AB
Clinicaltrials.gov Identifier
Research summary
The goal of this trial is to investigate the effectiveness and safety of a new medicine called imlifidase to temporarily remove the antibodies and enable transplantation in children and adolescents between 1–17 years of age with kidney failure, also called end-stage kidney disease (ESKD) and who have a high level of antibodies.
An important part of the body's defences is antibodies. The role of antibodies is normally to protect against infections and keep one healthy, but antibodies can also be ready to attack foreign tissue, such as a new kidney transplant causing the body to reject the new kidney. Before the transplantation antibody levels are measured by a test called crossmatch test. If the crossmatch test is positive, it means that the patient has antibodies at high levels which will likely attack the new kidney. In this case the transplantation cannot take place.
Imlifidase is a new medicine that was approved in 2020 for use in adults (18 years and older) and works by breaking down a type of antibody in the body called immunoglobulin G (IgG). Imlifidase is given before a kidney transplantation to change a positive crossmatch test to negative and make a transplantation possible.
The trial will consist of two parts: the interventional trial period in which patients will be followed for 6 months after transplantation and a 5-year follow-up part to collect long-term data. The trial will include 19 visits to the clinic, 15 visits in the interventional part of the trial and 4 follow-up visits (at 1, 2, 3 and 5 years after transplantation).
The trial will enrol 10 participants in several countries in Europe, including 1 site in the UK (Great Ormond Street Hospital).
Children and adolescents with ESKD and high antibody levels that at present stop them from being transplanted, may benefit from treatment with imlifidase by making a kidney transplantation possible, become free from dialysis dependence and gain the improvements of life a kidney transplant offers.REC name
Wales REC 5
REC reference
23/WA/0351
Date of REC Opinion
31 Jan 2024
REC opinion
Further Information Favourable Opinion