Emulsified avacopan given through a nasogastric tube for patients with ANCA-associated vasculitis and diffuse alveolar hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 pharmacokinetic study enrolling up to six patients with active severe ANCA-associated vasculitis (GPA or MPA) complicated by diffuse alveolar hemorrhage who require mechanical ventilation. Participants will receive emulsified avacopan 30 mg twice daily administered via a nasogastric tube. Blood samples will be collected over a 72-hour period to characterize absorption and systemic exposure. The goal is to define pharmacokinetic behavior of NG-tube–administered avacopan to inform dosing and safety in critically ill, intubated patients.

Why it matters

Who can join: the full rules

Inclusion Criteria

* 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 Criteria

* 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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Ulrich Specks, MD — Mayo Clinic
• Study coordinator: Josie Baum
• Email: baum.josephine@mayo.edu
• Phone: 507-422-9010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.