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: Recruiting
Location: See all (12) 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
RECRUITING
Vienna
France
Centre Hospitalier Universitaire (CHU) de Rouen - Hôpital de Bois-Guillaume
RECRUITING
Bois-guillaume
Hôpital Necker - Enfants Malades
RECRUITING
Paris
Italy
Azienda Ospedaliera di Padova
RECRUITING
Padova
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Erasmus University Medical Center
RECRUITING
Rotterdam
Spain
Hospital Del Mar, Servicio de Nefrología
RECRUITING
Barcelona
Hospital Universitario del Vall d´Hebron
RECRUITING
Barcelona
Unidad de Trasplante Renal
RECRUITING
Barcelona
Hospital Universitario 12 De Octubre
RECRUITING
Madrid
Sweden
Karolinska University Hospital,
RECRUITING
Huddinge
Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Central Contact
clinicalstudyinfo@hansabiopharma.com
+46 46 16 56 70
Time Frame
Start Date: 2023-07-03
Estimated 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