Avacostar - (PASS)
ConditionANCA-associated Vasculitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVifor Fresenius Medical Care Renal Pharma
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsGroup A: Treated with avacopan for active AAV
Group B: Treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active AAV
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
Incidence rates of AE in the avacopan and non-avacopan groups
Time frame
up to 7 years2
AEs leading to discontinuation of therapy in the avacopan group
Time frame
up to 7 years3
Incidence of SAEs in the avacopan and non-avacopan groups
Time frame
up to 7 years4
Incidence of ADRs in the avacopan group
Time frame
up to 7 yearsSponsors and contacts
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Source ClinicalTrials.gov