Desensitisation with imlifidase prior to kidney transplant in highly sensitised childre
- Conditions
- Highly sensitised paediatric patients with a positive crossmatch against a living or deceased donor kidney.MedDRA version: 20.0Level: PTClassification code: 10023439Term: Kidney transplant rejection Class: 100000004870Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2022-500230-28-00
- Lead Sponsor
- Hansa Biopharma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 8
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 of 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 test determined by FCXM and/or CDCXM tests against the donor. For the DD patients, if physical crossmatch tests are not practically possible due to lack of time, patients may be included on a vXM predictive of a positive crossmatch test., Willingness and ability to comply with the protocol as judged by the investigator
Previous treatment with imlifidase, Any other reason that, in the view of the investigator, precludes transplantation, Breast feeding or pregnancy, if applicable, 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), Suspicion of Covid-19 infection or positive 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, CMV or EBV to a patient with negative serology (mismatch serology), Clinically relevant active infection(s) as judged by the investigator, Tuberculosis, Use of other investigational agents within 5 terminal elimination half-lives prior to the transplantation, IVIg treatment within 28 days prior to imlifidase treatment, 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, 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, ABO blood group incompatible transplantations (A2 and A2B kidneys will not be accepted for B recipients)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate crossmatch conversion with imlifidase treatment;Secondary Objective: To evaluate renal function, To evaluate human leukocyte antigen (HLA)/donor specific antibody (DSA) levels, To evaluate graft survival, To evaluate patient survival, To evaluate delayed graft function (DGF), To evaluate pharmacokinetic (PK) profile of imlifidase, To evaluate pharmacodynamic (PD) profile of imlifidase, To evaluate immunogenicity profile of imlifidase (anti-drug antibodies [ADAs]), To evaluate proportion of biopsy- and serology-confirmed antibody-mediated reactions (AMRs) and biopsy confirmed cell-mediated rejections (CMRs), To evaluate safety and tolerability of imlifidase treatment;Primary end point(s): Proportion of patients with conversion of a positive crossmatch test to negative within 24 hours after start of imlifidase treatment
- Secondary Outcome Measures
Name Time Method