Clinical trial
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
Name
20-HMedIdeS-20
Description
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.
Trial arms
Trial start
2023-07-03
Estimated PCD
2028-12-31
Trial end
2028-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Imlifidase administered in the 20-HMedIdeS-19 (PAES) study
Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG.
Arms:
Imlifidase
Other names:
IdeS, HMED-IdeS, Idefirix
Best available treatment administered in the 20-HMedIdeS-19 (PAES) study
Normal transplantation routine Transplantation and pre- and post-transplantation therapies in accordance with the clinic's normal transplantation routine.
Arms:
Non-Comparative Concurrent Reference Cohort
Size
150
Primary endpoint
Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation (imlifidase cohort only)
5-years after transplantation
Eligibility criteria
Inclusion Criteria:
* Signed Informed Consent obtained before any trial-related procedures
* Willingness and ability to comply with the protocol
* Previously transplanted in the clinical trial 20-HmedIdeS-19 (PAES)
Exclusion Criteria:
* Inability by the judgment of the investigator to participate in the trial for other reasons
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a long-term follow-up trial following an open-label, non-randomized trial in highly sensitized adult kidney transplant patients with positive crossmatch (XM) against an available deceased donor.\n\nThe rational for the main trial, 20-HMedIdeS-19 (PAES), being non-randomized is that no other effective or approved desensitization protocol exists in deceased-donor kidney transplantation that would provide a suitable control. A non-comparative concurrent reference cohort from participating sites was included to address differences in-site practice and experience.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-03-07
1 organization
Organization
Hansa Biopharma