A Prospective, Observational Long-term Follow-up Trial of Kidney Transplant Patients Treated With Imlifidase or Plasma Exchange After an Active/Chronic Active Antibody-Mediated Rejection Episode

20-HMedIdes-18

The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection (AMR) in kidney transplant recipients. This is done by collecting data during an extended follow-up period of 3 years of clinical study trial 16-HMedIdeS-12, in which patients received either imlifidase or plasma exchange (PE) as AMR treatment. Data for parameters such as kidney graft survival, patient survival, kidney function, treatment of rebound of donor specific antibodies (DSA) and anti-drug antibodies (ADAs) are collected.

2021-01-21

2023-03-30

2023-03-30

Terminated

18

Inclusion Criteria: * Signed Informed Consent obtained before any trial-related procedures * Willingness and ability to comply with the protocol * Previous treatment with imlifidase or plasma exchange in the trial 16-HMedIdeS-12 Note: The primary objective of this trial is overall graft survival after treatment with imlifidase or plasma exchange. Therefore, subjects can also be included even if the subject did not fully complete the feeder trial follow up but was dosed with imlifidase or plasma exchange in the trial 16-HMedIdeS-12. Exclusion Criteria: • Inability by the judgement of the investigator to participate in the trial for any other reason

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples collected for DSA and ADA may be stored for a maximum of 5 years after completion of the trial.\n\nA full chain of custody is maintained for all samples throughout their life cycle.'}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2023-04-06