Tests imlifidase before kidney transplant in highly sensitised children
Tests imlifidase in children with kidney failure who are highly sensitised to donor kidneys.
Plain-language title generated from the registry record
Registry title: Imlifidase Prior to Kidney Transplant in Highly Sensitised Children
Key facts
- Where
- Rome, ItalySee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 17 years old?
Source: NCT05753930, who can take part
Where in Italy
- Ospedale Pediatrico Bambino GesùRome, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hansa Biopharma AB
- Trial code
- NCT05753930EU 2022-500230-28-00
- Record updated
- 10 November 2026
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: 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); 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: Previous treatment with imlifidase; IVIg treatment within 28 days prior to imlifidase treatment; Desensitisation treatment(s) within 1 month prior to the current transplantation; Malignancy within 3 years prior to transplantation; Any other reason that, in the view of the investigator, precludes transplantation; Use of other investigational agents within 5 terminal elimination half-lives prior to the 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; Suspicion of Covid-19 infection or positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test; Positive serology for human immunodeficiency virus (HIV); Clinical signs of hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus (CMV), or Epstein Barr virus (EBV) infection; Donor with positive serology for HIV, HBV, HCV or CMV to a patient with negative serology (mismatch serology). Mismatch serology for EBV in accordance with center specific standard procedures for transplantation of EBV negative recipients and at investigator's discretion; Clinically relevant active infection(s) as judged by the investigator; Tuberculosis or history of tuberculosis; Woman of fertile age and sexually active without adequate contraceptive measures to avoid pregnancy during the interventional trial period (i.e. up to 6 months after transplantation); ABO blood group incompatible transplantations (A2 and A2B kidneys will not be accepted for B recipients); Breast feeding or pregnancy, if applicable; Contemporaneous participation in medical device studies; Known mental incapacity or language barriers precluding patients'/parents'/legal guardians' adequate understanding of the informed consent information and the trial activities; Inability by the judgement of the investigator to participate in the trial for any other reason.