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Can a new drug tame vasculitis with fewer side effects?

NCT ID NCT05897684

Disease control Sponsor: Vifor Fresenius Medical Care Renal Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This study tracks the safety of avacopan, a medication for ANCA-associated vasculitis, an autoimmune disease that causes blood vessel inflammation. Researchers will compare side effects like liver injury, heart problems, serious infections, and cancer in people taking avacopan versus those on standard treatments. The goal is to see if avacopan offers a safer long-term option for managing this serious condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
avacopan
What this could lead to
If avacopan proves safer than current therapies, it could become a preferred treatment for ANCA-associated vasculitis.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. The results may take years to emerge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

507 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis granulomatosis with polyangiitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ANCA associated vasculitis

Contacts and locations

Locations

  • Addenbrookes Hospital

    Cambridge, United Kingdom

  • Barts Health

    London, United Kingdom

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, United Kingdom

  • Cardiff and Vale UHB

    Cardiff, United Kingdom

  • Charité University Medicine

    Berlin, Germany

  • East Kent Hospitals University NHS FT

    Canterbury, United Kingdom

  • Epsom & St. Helier NHS Trust

    Carshalton, United Kingdom

  • Hammersmith Hospital, Imperial College Healthcare NHS Trust

    London, United Kingdom

  • KRH Klinikum Siloah

    Hanover, Germany

  • Kings College Hospital

    London, United Kingdom

  • LMU

    Munich, Germany

  • Manchester University NHS Foundation Trust

    Manchester, United Kingdom

  • Medius Kliniken

    Plochingen, Germany

  • Municipal Hospital Dresden

    Dresden, Germany

  • NHS Greater Glasgow & Clyde

    Glasgow, United Kingdom

  • North Bristol NHS Trust

    Bristol, United Kingdom

  • Northern Care Alliance

    Salford, United Kingdom

  • Nottingham university hospitals NHS trust

    Nottingham, United Kingdom

  • Rheumatology Department, Oxford University Hospitals NHS Foundation Trust

    Oxford, United Kingdom

  • Rheumazentrum Ruhrgebiet

    Herne, Germany

  • Royal Berkshire NHS foundation trust

    Reading, United Kingdom

  • Royal Devon University Healthcare NHS Foundation Trust

    Exeter, United Kingdom

  • Royal Free

    London, United Kingdom

  • St Thomas' Hospital

    London, United Kingdom

  • St. Josef-Stift Sendenhorst

    Sendenhorst, Germany

  • Swansea Bay University LHB

    Swansea, United Kingdom

  • UHB NHS Foundation Trust

    Birmingham, United Kingdom

  • University Hospital Eppendorf

    Hamburg, Germany

  • University Hospital Essen

    Essen, Germany

  • University Hospital Freiburg

    Freiburg im Breisgau, Germany

  • University Hospital of Cologne

    Cologne, Germany

  • University Hospitals Coventry and Warwickshire

    Coventry, United Kingdom

  • University Hospitals of Leicester NHS Trust

    Leicester, United Kingdom

  • University Medical Center Göttingen

    Göttingen, Germany

  • York & Scarborough Teaching Hospitals NHS FT

    York, United Kingdom

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