Avacostar - (PASS)
Avacostar
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)
1 other identifier
observational
507
2 countries
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Longer than P75 for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 9, 2023
CompletedStudy Start
First participant enrolled
September 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
July 24, 2026
July 1, 2026
7.2 years
June 1, 2023
July 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the incidence of defined MESIs
To evaluate the incidence of defined MESIs in patients with AAV commencing avacopan. MESIs include liver injury, cardiac safety, serious infection, and malignancy.
up to 7 years
Secondary Outcomes (22)
Incidence rates of AE in the avacopan and non-avacopan groups
up to 7 years
AEs leading to discontinuation of therapy in the avacopan group
up to 7 years
Incidence of SAEs in the avacopan and non-avacopan groups
up to 7 years
Incidence of ADRs in the avacopan group
up to 7 years
Incidence of SADRs in the avacopan group
up to 7 years
- +17 more secondary outcomes
Study Arms (2)
Treated with avacopan for active AAV
The study will enrol approximately 250 adult patients diagnosed with AAV (MPA or GPA) treated with avacopan for active severe AAV.
Treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active AAV
The study will enrol approximately 250 adult patients diagnosed with AAV (MPA or GPA) treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Charité University Medicine
Berlin, Germany
University Hospital of Cologne
Cologne, Germany
Municipal Hospital Dresden
Dresden, Germany
University Hospital Essen
Essen, Germany
University Hospital Freiburg
Freiburg im Breisgau, Germany
University Medical Center Göttingen
Göttingen, Germany
University Hospital Eppendorf
Hamburg, Germany
KRH Klinikum Siloah
Hanover, Germany
Rheumazentrum Ruhrgebiet
Herne, Germany
LMU
Munich, Germany
Medius Kliniken
Plochingen, Germany
St. Josef-Stift Sendenhorst
Sendenhorst, Germany
UHB NHS Foundation Trust
Birmingham, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
East Kent Hospitals University NHS FT
Canterbury, United Kingdom
Cardiff and Vale UHB
Cardiff, United Kingdom
Epsom & St. Helier NHS Trust
Carshalton, United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
Exeter, United Kingdom
NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Barts Health
London, United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom
Kings College Hospital
London, United Kingdom
Royal Free
London, United Kingdom
St Thomas' Hospital
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Nottingham university hospitals NHS trust
Nottingham, United Kingdom
Rheumatology Department, Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Royal Berkshire NHS foundation trust
Reading, United Kingdom
Northern Care Alliance
Salford, United Kingdom
Swansea Bay University LHB
Swansea, United Kingdom
York & Scarborough Teaching Hospitals NHS FT
York, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2023
First Posted
June 9, 2023
Study Start
September 11, 2023
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share