Clinical trial • Phase IV • Nephrology|Immunology
Felzartamab for Late antibody-mediated renal transplant rejection|Renal transplant rejection
Phase IV trial of Felzartamab for Late antibody-mediated renal transplant rejection|Renal transplant rejection. 30 participants.
Overview
- Trial Therapeutic Area
- Nephrology|Immunology
- Trial Disease
- Late antibody-mediated renal transplant rejection|Renal transplant rejection
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 14-10-2024
- First CTIS Authorization Date
- 11-12-2024
Trial design
Phase IV trial across 2 sites in Austria, Germany.
- Target Sample Size
- 30
Eligibility
Recruits 30 No vulnerable populations selected (isVulnerablePopulationSelected: false). Consent/assent handling not detailed in the record..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Consent/assent handling not detailed in the record.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 50
- Consent Approach
- Not specified in the record.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 30
Austria
- Earliest CTIS Part Ii Submission Date
- 29-10-2024
- Latest Decision Or Authorization Date
- 28-04-2025
- Processing Time Days
- 181
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Division of Nephrology and Dialysis, Department of Medicine III
- Principal Investigator Name
- Georg Böhmig
- Principal Investigator Email
- georg.boehmig@meduniwien.ac.at
- Contact Person Name
- Georg Böhmig
- Contact Person Email
- georg.boehmig@meduniwien.ac.at
Germany
- Earliest CTIS Part Ii Submission Date
- 29-10-2024
- Latest Decision Or Authorization Date
- 28-02-2025
- Processing Time Days
- 122
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Nephrology
- Principal Investigator Name
- Klemens Budde
- Principal Investigator Email
- klemens.budde@charite.de
- Contact Person Name
- Klemens Budde
- Contact Person Email
- klemens.budde@charite.de
Sponsor
Primary sponsor
- Full Name
- Medical University Of Vienna
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Austria
Investigational products
- Investigational Product Name
- Felzartamab
- Active Substance
- Felzartamab
- Modality
- Monoclonal antibody
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