Vifor Fresenius Medical Care Renal Pharma is leading a new observational study that aims to evaluate the incidence of defined medical events of special interest in individuals diagnosed with ANCA-associated vasculitis (AAV) who are starting treatment with and without avacopan.
The study, known as Avacostar PASS (Post Authorization Safety Study), will enroll a prospective cohort of approximately 500 participants.
During the study, which is expected to last up to 7 years, the researchers will gather data from 2 groups of patients: 1 receiving avacopan treatment for active severe AAV, and the other receiving a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV.
The primary objective of Avacostar PASS is to evaluate the incidence of defined medical events of special interest, including liver injury, cardiac safety, serious infection, and malignancy.
Read more about AAV therapies
In addition, Avacostar PASS will assess other safety and efficacy measures over a duration of 7 years. These include the incidence of adverse events and serious adverse events in both the avacopan and nonavacopan groups, as well as adverse events leading to discontinuation of therapy, and incidence of adverse drug reactions and serious adverse drug reactions in the avacopan group.
Moreover, investigators will determine changes in estimated glomerular filtration rate, immunoglobulin G, creatine phosphokinase, alanine transaminase, aspartate transaminase, bilirubin, white blood cell count, albumin, and Vasculitis Damage Index score over time in both the avacopan and nonavacopan groups.
The study will also evaluate the time to first flare, use of concomitant immunosuppression over time and cumulative by treatment group, duration of glucocorticoid-free periods, proportion of glucocorticoid-free patients over time by treatment group, and duration of avacopan treatment based on the reason for treatment discontinuation.
Read more about AAV epidemiology
To enroll in the study, participants must be aged 18 years or older and must have a confirmed diagnosis of AAV, specifically, microscopic polyangiitis or granulomatosis with polyangiitis, showing active and severe disease at the time of initiating avacopan or nonavacopan standard of care induction therapy.
Participants must have started or plan to start avacopan, cyclophosphamide, or rituximab treatment for severe, active AAV within the past 6 months outside of an interventional clinical study.
The recruitment period (not yet recruiting) will last approximately 3 years, and patients will be followed until the last visit of the last participant, which will occur 4 years after the enrollment of the final participant.
Reference
Avacostar – (PASS) (Avacostar). ClinicalTrials.gov. June 9, 2023. Updated June 15, 2023. Accessed June 21, 2023.
