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

Highly sensitised patients who have undergone kidney transplantation after Idefirix (imlifidase) administration and less sensitized patients transplanted with compatible kidney transplant, serving as concurrent reference cohort

Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation(imlifidase cohort only)

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

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