NCT05654922 · Renovion, Inc.
Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant
What this study is about
The goal of this Phase 3 clinical trial is to compare ARINA-1 (a nebulized immunomodulatory agent) plus the usual treatment vs the usual treatment alone.
View original scientific description
The goal of this Phase 3 clinical trial is to compare ARINA-1 (a nebulized immunomodulatory agent) plus Standard of Care vs Standard of Care alone.
Interventions
DRUG
ARINA-1
ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH)
OTHER
Standard of care only
Standard 3-therapy immunosuppression regimen and azithromycin
Primary outcome measures
Percentage change from baseline in FEV1 (%ΔFEV1)
Time frame: 24 weeks
Week 24 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Bilateral lung transplant \>12 months from the time of Visit 1 / Randomization 2. Age 18-75 years old at the time of consent 3. Routinely followed at enrolling site 4. Willing and able to comply with visit schedule and at-home requirements 5. 10-24% decrease in FEV1 from the post-transplant baseline within the last 12 months. 6. Capable of giving informed consent 7. On a stable maintenance regimen of azithromycin for \>4 weeks prior to the Screening Visit 8. On a stable 2-agent or 3-agent immunosuppression regimen that includes a steroid, a calcineurin inhibitor (CNI), and, optionally, a cell cycle inhibitor (e.g., mycophenolate, azathioprine) \>4 weeks prior to Screening 9. If a woman of childbearing potential (WOCBP), must agree to use a reliable method of birth control for the entire duration of the study.
Exclusion criteria
- Positive urine pregnancy test at screening and baseline visit 2. Diagnosis of active congestive heart failure or symptomatic coron
Where
- Phoenix, Arizona
- Los Angeles, California
- San Diego, California
- Orlando, Florida
- Tampa, Florida
- Maywood, Illinois
- Iowa City, Iowa
- Baltimore, Maryland
- Minneapolis, Minnesota
- St Louis, Missouri
- New York, New York
- Cleveland, Ohio
And 6 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 9, 2025 · Source of record for eligibility and locations