ANCA-associated VasculitisAvacostarNCT05897684
Avacostar - (PASS)
An observational study of ANCA-associated Vasculitis, run by Vifor Fresenius Medical Care Renal Pharma at 35 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANCA-associated Vasculitis
- How many people
- 507 participants
- Where
- 35 sitesin 2 countries
- Study dates
- 11 Sep 2023to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United Kingdom23 sites
UHB NHS Foundation Trust
Birmingham
Bradford Teaching Hospitals NHS Foundation Trust
Bradford
North Bristol NHS Trust
Bristol
Addenbrookes Hospital
Cambridge
East Kent Hospitals University NHS FT
Canterbury
Cardiff and Vale UHB
Cardiff
Epsom & St. Helier NHS Trust
Carshalton
University Hospitals Coventry and Warwickshire
Coventry
Royal Devon University Healthcare NHS Foundation Trust
Exeter
NHS Greater Glasgow & Clyde
Glasgow
University Hospitals of Leicester NHS Trust
Leicester
Barts Health
London
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London
Kings College Hospital
London
Royal Free
London
St Thomas' Hospital
London
Manchester University NHS Foundation Trust
Manchester
Nottingham university hospitals NHS trust
Nottingham
Rheumatology Department, Oxford University Hospitals NHS Foundation Trust
Oxford
Royal Berkshire NHS foundation trust
Reading
Northern Care Alliance
Salford
Swansea Bay University LHB
Swansea
York & Scarborough Teaching Hospitals NHS FT
York
Germany12 sites
Charité University Medicine
Berlin
University Hospital of Cologne
Cologne
Municipal Hospital Dresden
Dresden
University Hospital Essen
Essen
University Hospital Freiburg
Freiburg im Breisgau
University Medical Center Göttingen
Göttingen
University Hospital Eppendorf
Hamburg
KRH Klinikum Siloah
Hanover
Rheumazentrum Ruhrgebiet
Herne
LMU
Munich
Medius Kliniken
Plochingen
St. Josef-Stift Sendenhorst
Sendenhorst
About this study
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)
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.
Read the detailed description
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. Enrolled patients will be followed until the last patient last visit (LPLV) milestone, which will be 4 years after the last participant is enrolled.
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
- ANCA-associated Vasculitis
- Keywords
- anti-neutrophil cytoplasmic antibody (ANCA)-AAV
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of defined MESIs
To evaluate the incidence of defined MESIs in patients with AAV commencing avacopan. MESIs include liver injury, cardiac safety, serious infection, and malignancy.
Measured: up to 7 years
Secondary outcomes (22)
Incidence rates of AE in the avacopan and non-avacopan groups
Measured: up to 7 years
AEs leading to discontinuation of therapy in the avacopan group
Measured: up to 7 years
Incidence of SAEs in the avacopan and non-avacopan groups
Measured: up to 7 years
Incidence of ADRs in the avacopan group
Measured: up to 7 years
Incidence of SADRs in the avacopan group
Measured: up to 7 years
Change in eGFR over time in the avacopan and non-avacopan groups
Measured: up to 7 years
Change in IgG over time in the avacopan and non-avacopan groups
Measured: up to 7 years
Change in CPK over time in the avacopan and non-avacopan groups
Measured: up to 7 years
Change in ALT over time in the avacopan and non-avacopan groups
Measured: up to 7 years
Change in AST over time in the avacopan and non-avacopan groups
Measured: up to 7 years
Change in billirubin over time in the avacopan and non-avacopan groups
Measured: up to 7 years
Change in WBC over time in the avacopan and non-avacopan groups
Measured: up to 7 years
Change Albumin over time in the avacopan and non-avacopan groups
Measured: up to 7 years
Time to first flare over time in the avacopan and non-avacopan groups
A flare is defined in the BVAS as a score of more than 0. No flare is defined as a BVAS score equal to 0
Measured: up to 7 years
Change in VDI scores over time in the avacopan and non-avacopan groups
Measured: up to 7 years
Incidence of MESIs in the non-avacopan group
Measured: up to 7 years
Incidence rates of SAEs and MESIs in the avacopan group compared to the non-avacopan group,
Measured: up to 7 years
Incidence rates of MESIs in the avacopan group compared to the non-avacopan group,
Measured: up to 7 years
Use of concomitant immunosuppression over time and cumulative by treatment group,
Measured: up to 7 years
Duration of GC-free periods
Measured: up to 7 years
Proportion of GC-free patients over time by treatment group.
Measured: up to 7 years
Duration of treatment with avacopan by reason for treatment discontinuation.
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start11 Sep 2023
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ANCA-associated VasculitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Fresenius Medical Care Renal Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897684
- Sponsor's protocol ID
- CS-AVA-2022-0016
- Acronym
- Avacostar
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Publications
Jayne DRW, Luqmani R, Terrier B, Obergfell A, Pollet C, Boff M, Balcells-Oliver M, Hellmich B. Evaluation of the Long-Term Safety of Avacopan in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis in the Real World (AvacoStar): Protocol for a Noninterventional Prospective Cohort Study. JMIR Res Protoc. 2026 Mar 24;15:e81415. doi: 10.2196/81415.
PubMed 41875213
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05897684
- Acronym / sponsor ID
- Avacostar / CS-AVA-2022-0016
- Conditions
- ANCA-associated Vasculitis
- Keywords
- anti-neutrophil cytoplasmic antibody (ANCA)-AAV
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Vifor Fresenius Medical Care Renal PharmaIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Enrolled patients will be followed until the last patient last visit (LPLV) milestone, which will be 4 years after the last participant is enrolled.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the incidence of defined MESIs
Time frame: 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.
22 secondary outcomes
Incidence rates of AE in the avacopan and non-avacopan groups
Time frame: up to 7 years
AEs leading to discontinuation of therapy in the avacopan group
Time frame: up to 7 years
Incidence of SAEs in the avacopan and non-avacopan groups
Time frame: up to 7 years
Incidence of ADRs in the avacopan group
Time frame: up to 7 years
Incidence of SADRs in the avacopan group
Time frame: up to 7 years
Change in eGFR over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in IgG over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in CPK over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in ALT over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in AST over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in billirubin over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in WBC over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change Albumin over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Time to first flare over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in VDI scores over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Incidence of MESIs in the non-avacopan group
Time frame: up to 7 years
Incidence rates of SAEs and MESIs in the avacopan group compared to the non-avacopan group,
Time frame: up to 7 years
Incidence rates of MESIs in the avacopan group compared to the non-avacopan group,
Time frame: up to 7 years
Use of concomitant immunosuppression over time and cumulative by treatment group,
Time frame: up to 7 years
Duration of GC-free periods
Time frame: up to 7 years
Proportion of GC-free patients over time by treatment group.
Time frame: up to 7 years
Duration of treatment with avacopan by reason for treatment discontinuation.
Time frame: up to 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Derived from this study: PubMed 41875213Jayne DRW, Luqmani R, Terrier B, Obergfell A, Pollet C, Boff M, Balcells-Oliver M, Hellmich B. Evaluation of the Long-Term Safety of Avacopan in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis in the Real World (AvacoStar): Protocol for a Noninterventional Prospective Cohort Study. JMIR Res Protoc. 2026 Mar 24;15:e81415. doi: 10.2196/81415.
- Individual participant dataSharing planned: No
Related trials for ANCA-associated Vasculitis
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Recruiting
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Systemic Lupus Erythematosus, Systemic Sclerosis
RecruitingPhase 1
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
RecruitingPhase 1
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
RecruitingPhase 1
A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ANCA-associated Vasculitis, run by Vifor Fresenius Medical Care Renal Pharma at 35 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the incidence of defined MESIs (time frame: up to 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05897684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.