A Controlled, Open-label PA Efficacy and Safety Study in Imlifidase Desensitised Kidney Tx Patients With Positive XM Against a Deceased Donor Prior to Imlifidase Treatment, Including Non-comparative Registry and Concurrent Reference Cohorts
An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease (ESRD) patients with positive crossmatch (XM) against a deceased donor prior to desensitized with imlifidase and subsequent kidney transplantation. Two non-comparative reference cohorts are included to assess the impact of differences in post-transplantation management and outcome in less sensitized patients.
• Male or female patient aged 18-75 years
• ABO-compatible deceased donor aged 10-70 years
• ESRD active on the renal transplant waiting list of a kidney allocation system at the time of screening
• High sensitization with the highest unmet medical need unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitized patients
• Known DSA against an available deceased donor
• Positive crossmatch test determined by complement-dependent cytotoxicity crossmatch (CDCXM) and/or flow cytometric crossmatch (FCXM) against an available deceased donor. 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.
• Signed Informed Consent obtained before any trial-related procedures
• Willingness and ability to comply with the protocol
• Active on the renal transplant waiting list at a participating trial site at the time of screening
• An acceptable kidney transplant from a deceased donor
• Signed Informed Consent obtained before any trial related procedures
• Willingness and ability to comply with the protocol
• ESRD with a kidney transplant from a deceased donor
• Being transplanted in Europe after 01-Jan-2010 and included in the CTS registry
• Panel reactive antibodies (PRA) ≥ 50% (CDC T- or B-cell PRA, calculated panel reactive antibodies (cPRA), or virtual panel reactive antibodies (vPRA))
• Maintenance immunosuppression (intention to treat) with calcineurin inhibitor, mycophenolate mofetil (MMF) and corticosteroids in combination