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Avacostar - (PASS)
Sponsor: Vifor Fresenius Medical Care Renal Pharma
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2023-09-11
Completion Date
2030-12-01
Last Updated
2025-01-31
Healthy Volunteers
No
Conditions
Locations (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