Status:
TERMINATED
An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR
Lead Sponsor:
Hansa Biopharma AB
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
18+ years
Brief Summary
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 tra...
Detailed Description
AMR is one of the most challenging adverse events following kidney transplantation and a major cause of graft dysfunction and graft loss. AMR is triggered by donor-specific antibodies (DSA).Transplant...
Eligibility Criteria
Inclusion
- 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
- • Inability by the judgement of the investigator to participate in the trial for any other reason
Key Trial Info
Start Date :
January 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04711850
Start Date
January 20 2021
End Date
March 30 2023
Last Update
May 28 2025
Active Locations (7)
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1
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie MUW
Vienna, Austria, 1090
2
Hôpital Pellegrin
Bordeaux, France, 33076
3
CHU Grenoble Alpes - Néphrologie, dialyse et transplantation
Grenoble, France, 38043
4
Hôpital Saint-Louis. Service de Néphrologie et Transplantation
Paris, France, 75475