AVACOSTAR
Research type
Research Study
Full title
A Post-Authorisation Safety Study (PASS) to evaluate the Incidence of Safety Events of Interest in Patients treated with avacopan for ANCA-associated Vasculitis (AAV)
IRAS ID
318568
Contact name
David Jayne
Contact email
Sponsor organisation
Vifor Fresenius Medical Care Renal Pharma France
Clinicaltrials.gov Identifier
NCT05897684, ClinicalTrials.gov
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
This is a non-interventional Post-authorisation Safety Study (PASS) that will collect data from 2 groups of patients: those treated with avacopan for active ANCA-associated vasculitis (AAV), and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active AAV.
The study will be conducted in Germany and United Kingdom. Additional countries may be considered according to availability of avacopan and suitability for the study. The overall study duration is anticipated to be up to 7 years. The sponsor of this study is Vifor Fresenius Medical Care Renal Pharma France.
The rationale for this study is to gain information on the safety profile of avacopan in a real-world setting.REC name
London - Brent Research Ethics Committee
REC reference
23/PR/0745
Date of REC Opinion
12 Jul 2023
REC opinion
Favourable Opinion