Status:
RECRUITING
A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group
Lead Sponsor:
Hansa Biopharma AB
Conditions:
Long Term Efficacy and Safety
Eligibility:
All Genders
19-76 years
Phase:
PHASE3
Brief 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.
Detailed Description
This is a long-term follow-up trial to the post-authorisation efficacy and safety (PAES) trial (trial 20-HMedIdeS-19). The trial will include patients who participated in the PAES trial and were trans...
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
Key Trial Info
Start Date :
July 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05937750
Start Date
July 3 2023
End Date
April 30 2030
Last Update
January 26 2026
Active Locations (13)
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1
Medizinische Universitaet Wien
Vienna, Austria, 1090
2
Nephrology Clinic Vídeňská 1958/9
Prague, Czechia, 140-21
3
Centre Hospitalier Universitaire (CHU) de Rouen - Hôpital de Bois-Guillaume
Bois-Guillaume, Normandy, France, 76230
4
Hôpital Necker - Enfants Malades
Paris, France, 75015