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.
Who can participate
Age range18 Years ā 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Male or female patient aged 18-75 years
ā. ABO-compatible deceased donor aged 10-70 years
ā. ESRD active on the renal transplant waiting list of a kidney allocation system at the time of screening
ā. 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
ā. Known DSA against an available deceased donor
ā. 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.
ā. Signed Informed Consent obtained before any trial-related procedures
ā. Willingness and ability to comply with the protocol
Exclusion criteria
ā. Use of investigational agents within 5 terminal elimination half-lives prior to the transplantation
ā. Malignancy within 5 years prior to transplantation
ā. Positive serology for human immunodeficiency virus (HIV)
ā
What they're measuring
1
Graft failure-free survival 1 year after transplantation following imlifidase treatment