A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group
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
Hansa Biopharma AB
150 participants
Jul 3, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria1
- Inability by the judgment of the investigator to participate in the trial for other reasons
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Interventions
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.
Normal transplantation routine Transplantation and pre- and post-transplantation therapies in accordance with the clinic's normal transplantation routine.
Locations(14)
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NCT05937750