ClinicaliQ Trial Snapshot
- Imlifidase Prior to Kidney Transplant in Highly Sensitised Children — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT05753930.
- What is being tested: Imlifidase, an IgG-degrading enzyme, is being evaluated for its efficacy and safety in enabling successful kidney transplantation in highly sensitized children (aged 1-17 years) with end-stage renal disease who would otherwise face prolonged waiting times or transplant ineligibility.
- Patient eligibility overview: The trial targets paediatric patients with ESRD who are highly sensitized (having elevated panel reactive antibodies), making them at high immunological risk for transplant rejection; these children typically face significant barriers to finding compatible donor kidneys.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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…
Eligibility Snapshot
- : 1. Signed Informed Consent obtained from patient/parent/legal guardian/independent witness (depending on patient's age) before any trial-related procedures 2. Highly sensitised patient with panel reactive antibodies (PRA) ≥80% 3. 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 6. 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) 7. 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. 8. Willingness and ability to comply with the protocol as judged by the investigator
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.