Actively Recruiting
Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube
Led by Mayo Clinic · Updated on 2026-04-29
6
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the 72-hour pharmacokinetics of emulsified avacopan at a dose of 30 mg twice daily given to up to 6 patients with active severe GPA or MPA with diffuse alveolar hemorrhage (DAH) requiring mechanical ventilation for respiratory support.
CONDITIONS
Official Title
Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ANCA-associated vasculitis (granulomatosis with polyangiitis or microscopic polyangiitis) according to the Second Chapel Hill Consensus Conference definitions
- Positive for ANCA against PR3 or MPO
- Presence of diffuse alveolar hemorrhage
- Respiratory failure requiring mechanical ventilation
- Severe newly diagnosed or relapsing disease requiring standard treatment
- Minimum Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS-WG) of 3
- Need for standard remission induction therapy for active severe ANCA-associated vasculitis
You will not qualify if you...
- Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA)
- History of severe allergic reaction to avacopan
- History of anti-glomerular basement membrane disease
- Use of avacopan within the last 5 days
- Use of strong CYP3A4 inhibitors
- Liver function tests (AST, ALT, alkaline phosphatase, or bilirubin) more than 2.5 times the upper limit of normal unless caused by vasculitis
- Evidence of active or prior Hepatitis B, Hepatitis C, or HIV infection
- Active serious infection
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
J
Josie Baum
CONTACT
M
Michael Stachowitz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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