A prospective, post-authorisation long-term follow up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort

简要总结

主要结局

次要结局

• Graft failure-free survival (%) up to 5 years after transplantation (non-comparativeconcurrent reference cohort only)
• Graft failure-free survival (%) up to 2 and 3 years after transplantation
• Renal function as evaluated by estimated Glomerular Filtration Rate (eGFR) andserum/plasma creatinine levels
• Patient survival (%) after transplantation
• Graft survival (%) after transplantation
• HLA/DSA levels (imlifidase cohort only)
• ADA levels (imlifidase cohort only)
• Proportion of patients (%) with biopsy- and serology (DSA)-confirmed AMRs
• Proportion of patients (%) with biopsy confirmed CMRs.
• Treatment of graft rejection episodes
• Adverse events (AEs)/serious adverse events (SAEs) suspected to be related toimlifidase treatment (imlifidase cohort only)
• Ongoing immunosuppressive medication
• Comorbidity
• Change in patient reported life participation, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health domain “Ability to participate in social roles & activities, PROMIS-SF-8a”, from baseline to 5 years after transplantation