An observational study in ANCA-associated Vasculitis, sponsored by Vifor Fresenius Medical Care Renal Pharma. Active, not recruiting at 35 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Vifor Fresenius Medical Care Renal Pharma (part of CSL Limited) · Observational
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.
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.
157 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 75 are open to participants now.
This study's enrollment of 507 is above the median of 120 across 35 observational studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.
Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →Vifor Fresenius Medical Care Renal Pharma is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
First submitted after Vifor Fresenius Medical Care Renal Pharma became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study will enrol approximately 250 adult patients diagnosed with AAV (MPA or GPA) treated with avacopan for active severe 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.
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.
Time frame: up to 7 years
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
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
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
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis →
Vifor Fresenius Medical Care Renal Pharma →