Imlifidase Prior to Kidney Transplant in Highly Sensitised Children

Exclusion Criteria

• •1. Previous treatment with imlifidase
• •2. IVIg treatment within 28 days prior to imlifidase treatment
• •3. Desensitisation treatment(s) within 1 month prior to the current transplantation
• •4. Hypersensitivity to the active substance (imlifidase) or to any of the excipients and to other immunosuppressive drugs specified in the protocol
• •5. Ongoing serious infections
• •6. Present, or history of, thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
• •7. 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
• •8. Malignancy within 3 years prior to transplantation
• •9. ABO blood group incompatible transplantations (A2 and A2B kidneys will not be accepted for B recipients)
• •10. Any other reason that, in the view of the investigator, precludes transplantation
• •11. Breast feeding or pregnancy, if applicable
• •12. 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)
• •13. Suspicion of Covid-19 infection or positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test
• •14. Positive serology for human immunodeficiency virus (HIV)
• •15. Clinical signs of hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus (CMV), or Epstein Barr virus (EBV) infection
• •16. Donor with positive serology for HIV, HBV, HCV, CMV or EBV to a patient with negative serology (mismatch serology)
• •17. Clinically relevant active infection(s) as judged by the investigator
• •18. Tuberculosis or history of tuberculosis
• •19. Use of other investigational agents within 5 terminal elimination half-lives prior to the transplantation
• •20. Contemporaneous participation in medical device studies
• •21. Known mental incapacity or language barriers precluding patients'/parents'/legal guardians' adequate understanding of the informed consent information and the trial activities
• •22. Inability by the judgement of the investigator to participate in the trial for any other reason