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Study of Avacopan for Diffuse Alveolar Hemorrhage

This study is looking at how the body handles a medicine called avacopan when it's given through a feeding tube (nasogastric tube) to people with a serious lung condition called diffuse alveolar hemorrhage (DAH). DAH is often caused by a type of blood vessel inflammation called ANCA-associated vasculitis (specifically granulomatosis with polyangiitis or microscopic polyangiitis). To join, you must be an adult with ANCA-associated vasculitis, test positive for ANCA, have DAH, and need a breathing machine. Researchers will measure the amount of avacopan in your blood over 72 hours to see how it's absorbed and processed. This study is currently unclear on its recruitment status and plans to include up to 6 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It will involve up to 6 participants.
What's involved
Participants will receive avacopan capsules, dissolved in water, through a nasogastric tube twice daily. Blood levels of avacopan will be measured over 72 hours.
Compensation
Not stated in the trial record.
Follow-up
The study will measure avacopan blood levels over 72 hours.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07556484

Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube

Recruiting
PHASE1Ages 18+InterventionalTreatment
Mayo Clinic
~6 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Avacopan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Avacopan blood level over time
Measured over 72 hours

Conditions

Diffuse Alveolar Hemorrhage
Antineutrophil Cytoplasmic Antibody Positive Vasculitis

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Diffuse alveolar hemorrhageGranulomatosis with PolyangiitisMicroscopic PolyarteritisFanconi Anemia Group A Protein

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Ulrich Specks, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Josie Baum
[email protected]
507-422-9010
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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.
Pregnancy and breastfeeding

What this trial measures

  • Change in Avacopan blood level over time72 hours

    The primary objective of this study is to determine the blood (serum) level changes of Avacopan over time (pharmacokinetics) when Avacopan capsules are solubilized in heated water and administered to patients with Diffuse Alveolar Hemorrhage (DAH) due to GPA or MPA via nasogastric tube. Blood will be drawn pre-dose, post-dose 30 minutes, 1-hour, 2-hour, 4-hour, and 6-hour for the first dose and pre-dose for the remaining 72 hours and stored for analysis.