Using avacopan for treating ANCA-associated vasculitis in real-world settings
Evaluating Clinical Practice of Early Access Avacopan Treatment for ANCA-associated Vasculitis in European Countries
Leiden University Medical Center · NCT06794827
This study looks at how well avacopan works for treating people with ANCA-associated vasculitis in real-life situations across Europe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center (other) |
| Locations | 1 site (Leiden) |
| Trial ID | NCT06794827 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the variation in clinical practice regarding the early use of avacopan in patients with ANCA-associated vasculitis (AAV) across Europe. It will describe patient characteristics, treatment indications, and clinical outcomes associated with avacopan treatment. By focusing on real-world data, the study seeks to identify key issues in the implementation of avacopan, ultimately addressing knowledge gaps and improving patient care. The cohort will consist of AAV patients who have initiated treatment with avacopan, allowing for a comprehensive understanding of its effects and associated treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a confirmed diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) who are starting treatment with avacopan.
Not a fit: Patients without active AAV disease or those under 16 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and accessibility of avacopan treatment for patients with ANCA-associated vasculitis.
How similar studies have performed: While this study focuses on real-world data, similar observational studies have shown promise in understanding treatment variations and outcomes in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Established diagnosis of GPA or MPA * Treatment (initiation) with avacopan * Informed consent for use of medical data Exclusion Criteria: * If there is no AAV disease activity present that can be supported by an objectifiable clinical measure or assessment * If a subject is below 16 years old
Where this trial is running
Leiden
- Leiden University Medical Center — Leiden, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Y.K. Onno Teng — Leiden University Medical Center
- Study coordinator: Y.K.O. Teng, MD, PhD
- Email: y.k.o.teng@Lumc.nl
- Phone: +31715262148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ANCA Associated Vasculitis