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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
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

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charite University Medicine
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BerlinGermanyUnknown status
University Hospital of Cologne
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CologneGermanyUnknown status
Municipal Hospital Dresden
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DresdenGermanyUnknown status
University Hospital Essen
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EssenGermanyUnknown status
University Hospital Freiburg
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Freiburg im BreisgauGermanyUnknown status
University Medical Center Göttingen
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GöttingenGermanyUnknown status
University Hospital Eppendorf
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HamburgGermanyUnknown status
KRH, Klinikum Siloah
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HanoverGermanyUnknown status
Rheumazentrum Ruhrgebiet
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HerneGermanyUnknown status
LMU
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MunichGermanyUnknown status
Medius Kliniken
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PlochingenGermanyUnknown status
St. Josef-Stift Sendenhorst
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SendenhorstGermanyUnknown status
UHB NHS Foundation Trust
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BirminghamUnited KingdomUnknown status
Bradford Teaching Hospitals NHS Foundation Trust
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BradfordUnited KingdomUnknown status
North Bristol NHS Trust
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BristolUnited KingdomUnknown status
Addenbrookes Hospital
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CambridgeUnited KingdomUnknown status
East Kent Hospitals University NHS FT
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CanterburyUnited KingdomUnknown status
Cardiff and Vale UHB
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CardiffUnited KingdomUnknown status
Epsom & St. Helier NHS Trust
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CarshaltonUnited KingdomUnknown status
University Hospitals Coventry and Warwickshire
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CoventryUnited KingdomUnknown status
Royal Devon University Healthcare NHS Foundation Trust
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ExeterUnited KingdomUnknown status
NHS Greater Glasgow & Clyde
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GlasgowUnited KingdomUnknown status
University Hospitals of Leicester NHS Trust
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LeicesterUnited KingdomUnknown status
St Thomas Hospital
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LondonUnited KingdomUnknown status
Royal Free
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LondonUnited KingdomUnknown status
Hammersmith Hospital, Imperial College Healthcare NHS Trust
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LondonUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
Barts Health
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LondonUnited KingdomUnknown status
Manchester University NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust
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NottinghamUnited KingdomUnknown status
Rheumatology Department, Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomUnknown status
Royal Berkshire NHS Foundation Trust
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ReadingUnited KingdomUnknown status
Northern Care Alliance
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SalfordUnited KingdomUnknown status
Swansea Bay University LHB
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SwanseaUnited KingdomUnknown status
York & Scarborough Teaching Hospitals NHS FT
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YorkUnited KingdomUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.