Imlifidase Prior to Kidney Transplant in Highly Sensitised Children (NCT05753930) | Clinical Trial Compass
RecruitingPhase 2
Imlifidase Prior to Kidney Transplant in Highly Sensitised Children
Finland, France, Spain10 participantsStarted 2023-06-02
Plain-language summary
The goal of this clinical trial is to learn about the efficacy and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD).
The main questions it aims to answer are:
* Does imlifidase treatment result in crossmatch conversion that enables transplantation?
* How is the function of the transplanted kidney?
The participants will be hospitalised in accordance with the normal routines for transplanted patients. The patients will receive medication to prevent rejection of the donor kidney, and because such treatment make the body more vulnerable medications to prevent infections.
Who can participate
Age range
1 Year – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed Informed Consent obtained from patient/parent/legal guardian/independent witness (depending on patient's age) before any trial-related procedures
. Highly sensitised patient with panel reactive antibodies (PRA) ≥80%
. Male or female patient between the age of 1 to 17 years (up to the day before the 18th birthday) at the time of screening
. Patient with end-stage renal disease (ESRD) and waiting for a renal transplant from a living or deceased donor
. Patient must be transplantable (including size mismatch) at the time of obtaining informed consent for trial participation
. Patients who have previously undergone desensitisation unsuccessfully with plasmapheresis/IVIg/anti-CD20 or have an anti-HLA antibody status deemed too difficult to make a successful desensitisation (judgement based on physicians' previous experience with similar patients)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with conversion of a positive crossmatch test to negative within 24 hours after start of imlifidase treatment
Timeframe: From start of imlifidase administration to 24 hours
. Positive crossmatch (XM) test determined by flow cytometry crossmatch (FCXM) and/or complement-dependent cytotoxicity crossmatch (CDCXM) tests against the donor. For the DD patients, if physical XM tests are not practically possible due to lack of time, patients may be included on a virtual crossmatch (vXM) predictive of a positive XM test.
. Willingness and ability to comply with the protocol as judged by the investigator
Exclusion criteria
. Previous treatment with imlifidase
. IVIg treatment within 28 days prior to imlifidase treatment
. Desensitisation treatment(s) within 1 month prior to the current transplantation
. Hypersensitivity to the active substance (imlifidase) or to any of the excipients and to other immunosuppressive drugs specified in the protocol
. Ongoing serious infections
. Present, or history of, thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
. At the time of transplantation: severe other condition requiring treatment and close monitoring e.g. cardiac failure ≥ grade 4 (New York Heart Association), unstable coronary disease, active peripheral vascular disease, proven hypercoagulable conditions/events or oxygen dependent respiratory disease
. Malignancy within 3 years prior to transplantation