A study aiming to collect data and provide a better understanding of the long-term outcome of imlifidase in treatment of immunological graft rejection in kidney transplant patients
Phase 1
- Conditions
- Antibody-mediated rejection in kidney transplant patientsMedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2020-004777-49-AT
- Lead Sponsor
- Hansa Biopharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
• Signed Informed Consent obtained before any trial-related procedures
• Willingness and ability to comply with the protocol
• Previous treatment with imlifidase or plasma exchange in trial 16-HMedIdeS-12
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
• Inability by the judgement of the investigator to participate in the trial for any other reason
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this trial is to evaluate kidney graft survival in subjects that have been treated with imlifidase or plasma exchange in association with AMR in trial 16-HMedIdeS-12 (referred to as the feeder trial).;Secondary Objective: • Evaluate overall graft survival at Year 1 and 2<br>• Evaluate patient survival at Year 3<br>• Evaluate kidney function at Year 1, 2 and 3<br>• Evaluate DSA levels at Year 1, 2 and 3<br>• Evaluate anti-imlifidase IgG levels at year 1, 2 and 3<br>• Investigate the occurrence of AMR episodes after completed the feeder trial<br>• Investigate the occurrence of other graft rejection episodes;Primary end point(s): The primary endpoint of this trial is the overall graft survival, evaluated at Year 3.;Timepoint(s) of evaluation of this end point: Year 3
- Secondary Outcome Measures
Name Time Method