NCT05897684Active, not recruiting
Avacostar - (PASS)
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)
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 507 (actual)
- First submitted
- 1 Jun 2023
- Start date
- 11 Sept 2023
- Primary completion date
- 1 Dec 2030
- Lead sponsor
- Vifor Fresenius Medical Care Renal Pharma
- Diseases
- ANCA-associated vasculitis
- NCT number
- NCT05897684
What you commit to
- Study type: Observational
- Participants enrolled: 507
- From 11 Sept 2023 to the primary completion date, 1 Dec 2030
- 35 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite University Medicine Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| University Hospital of Cologne Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Municipal Hospital Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| University Hospital Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| University Hospital Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| University Medical Center Göttingen Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
| University Hospital Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| KRH, Klinikum Siloah Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Rheumazentrum Ruhrgebiet Coordinator of this site? Confirm its status | Herne | Germany | Unknown status |
| LMU Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Medius Kliniken Coordinator of this site? Confirm its status | Plochingen | Germany | Unknown status |
| St. Josef-Stift Sendenhorst Coordinator of this site? Confirm its status | Sendenhorst | Germany | Unknown status |
| UHB NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Bradford Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| North Bristol NHS Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Addenbrookes Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| East Kent Hospitals University NHS FT Coordinator of this site? Confirm its status | Canterbury | United Kingdom | Unknown status |
| Cardiff and Vale UHB Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Epsom & St. Helier NHS Trust Coordinator of this site? Confirm its status | Carshalton | United Kingdom | Unknown status |
| University Hospitals Coventry and Warwickshire Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
| Royal Devon University Healthcare NHS Foundation Trust Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| NHS Greater Glasgow & Clyde Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| University Hospitals of Leicester NHS Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| St Thomas Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Free Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Hammersmith Hospital, Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Barts Health Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Rheumatology Department, Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Royal Berkshire NHS Foundation Trust Coordinator of this site? Confirm its status | Reading | United Kingdom | Unknown status |
| Northern Care Alliance Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Swansea Bay University LHB Coordinator of this site? Confirm its status | Swansea | United Kingdom | Unknown status |
| York & Scarborough Teaching Hospitals NHS FT Coordinator of this site? Confirm its status | York | United Kingdom | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.