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Observational study on avacopan for ANCA-associated vasculitis

Avacostar - A Post Authorization Safety Study (PASS) to Evaluate the Incidence of Safety Events of Interest in Patients Treated With Avacopan for ANCA-associated Vasculitis (AAV)

Observational Vifor Fresenius Medical Care Renal Pharma · NCT05897684

This study is testing how well avacopan works for people with severe ANCA-associated vasculitis compared to standard treatments like cyclophosphamide or rituximab over several years.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorVifor Fresenius Medical Care Renal Pharma Industry-sponsored
Drugs / interventionsrituximab, cyclophosphamide
Locations35 sites (Berlin and 34 other locations)
Trial IDNCT05897684 on ClinicalTrials.gov

What this trial studies

The Avacostar PASS is a non-interventional, multi-national, prospective cohort study designed to collect data from two groups of patients with active severe ANCA-associated vasculitis (AAV). One group will receive avacopan, while the other will be treated with standard care using cyclophosphamide or rituximab. The study will follow participants for up to 7 years, including a recruitment phase of approximately 3 years, to evaluate the incidence of specific medical events related to the treatments. Data will be collected both prospectively and, if necessary, retrospectively for up to 6 months prior to enrollment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with active severe ANCA-associated vasculitis who are starting treatment with avacopan or standard care.

Not a fit: Patients currently participating in other interventional studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of avacopan compared to traditional therapies for patients with severe AAV.

How similar studies have performed: While this study is observational, previous studies on avacopan have shown promising results, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Berlin and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ANCA-associated Vasculitisanti-neutrophil cytoplasmic antibody-AAV
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.