ARINA-1 for Bronchiolitis Obliterans Syndrome
Trial Summary
Will I have to stop taking my current medications?
The trial requires participants to be on a stable maintenance regimen of azithromycin and a stable 3-agent immunosuppression regimen for more than 4 weeks before the screening. If you are currently using an mTOR inhibitor, azathioprine, or have recently changed certain medications, you may need to adjust your current medications to participate.
What data supports the effectiveness of the drug ARINA-1 for Bronchiolitis Obliterans Syndrome?
What makes the drug ARINA-1 unique for treating Bronchiolitis Obliterans Syndrome?
What is the purpose of this trial?
This trial is testing ARINA-1, a new treatment added to usual care, for lung transplant patients at risk of a serious lung condition called BOS. The goal is to see if ARINA-1 can prevent the condition from getting worse and improve patients' quality of life. The trial involves periodic health monitoring to track progress and any side effects.
Research Team
Ramsey Hachem, MD
Principal Investigator
Barnes-Jewish Hospital / Washington University
Eligibility Criteria
This trial is for adults aged 18-75 who've had a bilateral lung transplant over a year ago and are experiencing a decline in lung function. They must be on stable medications, including azithromycin and immunosuppressants, willing to follow the study schedule, and women of childbearing age must use birth control. Exclusions include recent use of certain therapies or supplements, unresolved lung damage, severe heart or kidney disease, participation in other trials recently, and specific treatments within set timeframes.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ARINA-1 plus Standard of Care or Standard of Care alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ARINA-1
ARINA-1 is already approved in United States for the following indications:
- Prevention of bronchiolitis obliterans syndrome (BOS) progression in bilateral lung transplant patients (Fast Track designation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Renovion, Inc.
Lead Sponsor