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) (AVACOSTAR)

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.

Principal Investigator

Prof Raashid Luqmani

Contact us

Email: gail.lang@ndorms.ox.ac.uk

IRAS number

318568