Avacopan given by feeding tube in vasculitis with severe lung bleeding
Studies how the body handles avacopan in ventilated adults with vasculitis and lung bleeding.
Plain-language title generated from the registry record
Registry title: Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube
Key facts
- Where
- Rochester, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Mayo Clinic in RochesterRochester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mayo Clinic
- Trial code
- NCT07556484
- Record updated
- 20 October 2026
- Original description
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.Read full original descriptionShow less
Pharmacokinetics Of Emulsified Avacopan In ANCA-associated Vasculitis With Severe Diffuse Alveolar Hemorrhage
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.
Inclusion: Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis MPA); Positivity for ANCA, directed against PR3 or MPO; Diffuse alveolar hemorrhage; Respiratory failure requiring mechanical ventilation; Severe newly diagnosed disease or severe relapsing disease. Severe new or relapsing disease is defined as at least one major BVAS/WG item or a score ≥ 3 and the investigator deems standard treatment for severe disease is necessary; Minimum BVAS-WG of 3; Requirement of standard-of-care remission induction therapy for active severe ANCA-associated vasculitis (GPA or MPA).
Exclusion: Previous administration of avacopan within the last 5 days; Concomitant use of a strong CYP3A4 inhibitor; Evidence of prior active or current Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency (HIV) infection; Diagnosis with eosinophilic granulomatosis with polyangiitis (EGPA, formally Churg-Strauss syndrome) as defined by the Chapel Hill consensus conference; Allergies: History of severe allergic reaction to avacopan; History of documented anti-glomerular basement membrane disease (anti-GBM disease); Active serious infection, including localized infection; Aspartate aminotransferase [AST], alanine amino transferase [ALT], alkaline phosphatase, or total bilirubin elevation >2.5 times the upper limit of normal (unless attributed to vasculitis) on routine liver function testing obtained within 3 days prior to anticipated treatment with avacopan; Pregnancy and breastfeeding.