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Avacostar - (PASS)
Avacostar - (PASS)

NCT05897684

Active Not RecruitingN/A

Sponsor: Vifor Fresenius Medical Care Renal Pharma

Conditions: ANCA-associated Vasculitis

Countries: Germany, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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:

* Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.
Locations (35)
  • Berlin, Germany
  • Cologne, Germany
  • Dresden, Germany
  • Essen, Germany
  • Freiburg im Breisgau, Germany
  • Göttingen, Germany
  • Hamburg, Germany
  • Hanover, Germany
  • Herne, Germany
  • Munich, Germany
  • Plochingen, Germany
  • Sendenhorst, Germany
  • Birmingham, United Kingdom
  • Bradford, United Kingdom
  • Bristol, United Kingdom
  • Cambridge, United Kingdom
  • Canterbury, United Kingdom
  • Cardiff, United Kingdom
  • Carshalton, United Kingdom
  • Coventry, United Kingdom
  • Exeter, United Kingdom
  • Glasgow, United Kingdom
  • Leicester, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • Manchester, United Kingdom
  • Nottingham, United Kingdom
  • + 5 more on CT.gov