Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2023-09-11
2030-12-01
Brief Summary
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Detailed Description
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Germany and the United Kingdom (UK) have been selected for the study. Additional countries may be considered according to availability of avacopan and suitability for the study. Patients will be enrolled prospectively, but up to 6 months of data may be collected retrospectively if necessary. Baseline visit is defined as the day that induction treatment (avacopan or non-avacopan standard of care (SoC) cyclophosphamide or rituximab) is started for active severe AAV. Patients who started avacopan/SoC induction therapy for active severe AAV within 6 months of the enrolment visit and fulfil eligibility criteria may be enrolled in the PASS. Individual participant follow-up data will be collected periodically at routine clinic visits until the LPLV, which will be 4 years after the last participant is enrolled.
The primary objective of the study is:
To evaluate the incidence of defined Medical Events of Special Interest (MESIs) in patients with AAV commencing avacopan.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Vifor Fresenius Medical Care Renal Pharma
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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CS-AVA-2022-0016
Identifier Type: -
Identifier Source: org_study_id
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