Avacostar - (PASS)

NCT05897684 · tracked via the Priya Life Science UK tracker

Sponsor

Vifor Fresenius Medical Care Renal Pharma

Phase

Observational

Started

2023-09-11

Last updated

2026-07-24

Condition(s) studied

ANCA-associated Vasculitis

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.

Primary outcome measure(s)

To evaluate the incidence of defined MESIs — up to 7 years
To evaluate the incidence of defined MESIs in patients with AAV commencing avacopan. MESIs include liver injury, cardiac safety, serious infection, and malignancy.

Trial sites (35)

Facility	City	Region
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

More Vifor Fresenius Medical Care Renal Pharma trials in the UK

Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05897684 on ClinicalTrials.gov ↗ ← All trials in the UK