Imlifidase Prior to Kidney Transplant in Highly Sensitised Children

Prior treatment

• 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

Other illness

• 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

Age

• 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)

Other

• 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

• 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