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
Status: Active_not_recruiting
Location: See all (13) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 76
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Austria
Medizinische Universitaet Wien
Vienna
France
Centre Hospitalier Universitaire (CHU) de Rouen - Hôpital de Bois-Guillaume
Bois-guillaume
Hôpital Necker - Enfants Malades
Paris
Italy
Azienda Ospedaliera di Padova
Padova
Azienda Ospedaliero - Universitaria di Parma
Parma
Netherlands
Leiden University Medical Center
Leiden
Erasmus University Medical Center
Rotterdam
Spain
Hospital Del Mar, Servicio de Nefrología
Barcelona
Hospital Universitario del Vall d´Hebron
Barcelona
Unidad de Trasplante Renal
Barcelona
Hospital Universitario 12 De Octubre
Madrid
Sweden
Karolinska University Hospital,
Huddinge
Uppsala University Hospital
Uppsala
Time Frame
Start Date: 2023-07-03
Completion Date: 2030-04-30
Participants
Target number of participants: 150
Treatments
Experimental: Imlifidase
Imlifidase administered in the 20-HMedIdeS-19 (PAES) study
Experimental: Non-Comparative Concurrent Reference Cohort
Best available treatment administered in the 20-HMedIdeS-19 (PAES) study
Related Therapeutic Areas
Sponsors
Leads: Hansa Biopharma AB