Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Avacopan
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov