Avacostar - (PASS)
About the study
The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV. The overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Diagnosis of AAV (MPA or GPA), as determined by the Investigator according to their usual practice.
- Active, severe AAV at the time of commencing avacopan or non-avacopan SoC induction therapy, in the opinion of the Investigator.
- Age ≥18 years of either sex.
- Has provided written informed consent.
- Has commenced within the previous 6 months, or is planned to commence avacopan, cyclophosphamide or rituximab for the treatment of severe, active AAV outside of an interventional clinical study.
EXCLUSION CRITERIA
Exclusion Criteria:
• Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
ANCA-associated Vasculitis
Age
18+
Participants Needed
500
Est. Completion Date
Dec 1, 2030
Treatment Type
OBSERVATIONAL
Sponsor
Vifor Fresenius Medical Care Renal Pharma
ClinicalTrials.gov NCT Identifier
NCT05897684
Study Number
CS-AVA-2022-0016
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