6 Participants NeededMy employer runs this trial

Avacopan for Granulomatosis with Polyangiitis

JB
MS
Overseen ByMichael Stachowitz
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

US

Ulrich Specks, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

I have tested positive for ANCA against PR3 or MPO.
I have had bleeding in my lungs (diffuse alveolar hemorrhage).
I need a machine to help me breathe due to respiratory failure.
See 4 more

Exclusion Criteria

I have been diagnosed with anti-GBM disease in the past.
I have taken avacopan in the past 5 days.
History of severe allergic reaction to avacopan
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive emulsified avacopan at a dose of 30 mg twice daily for 3 consecutive days via NG tube

3 days
Daily visits for 3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Avacopan

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: AvacopanExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+