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RecruitingDiffuse Alveolar HemorrhageAntineutrophil Cytoplasmic Antibody Positive Vasculitis

Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Mayo Clinic

You may qualify if…

  • ✓ 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).

You may not qualify if…

  • ✕ 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)
  • ✕ Previous administration of avacopan within the last 5 days.
  • ✕ Concomitant use of a strong CYP3A4 inhibitor.
  • ✕ 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.
  • ✕ Evidence of prior active or current Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency (HIV) infection.
  • ✕ Active serious infection, including localized infection.

Where it's recruiting

Minnesota

Rochester

Source: ClinicalTrials.gov · NCT07556484 · last updated 2026-08-06

Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube · TrialPath