ARINA-1 for Preventing Bronchiolitis Obliterans Progression

Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant

Recruiting Phase 3 Interventional Study
Pre-Bronchiolitis Obliterans Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Renovion, Inc. · Industry
Who this trial is looking for

This trial is looking for people who have had a lung transplant over a year ago and are experiencing early signs of lung issues. Participants will take ARINA-1 and have regular check-ups to see how well it works compared to standard treatment alone.

Are You a Good Fit for This Trial?
Must be taking Azithromycin
Rules you out Unresolved diffuse alveolar damageChronic kidney disease stage IV or higher

You may be able to join if

  • I had a lung transplant more than 12 months ago.
  • I am between 18 and 75 years old.
  • I am regularly seen by my healthcare provider.
  • I can follow the study visit schedule.
  • I have had a 10-24% decrease in lung function in the past year.
  • I can provide informed consent.
  • I have been taking azithromycin consistently for over 4 weeks.
  • I am on a stable immunosuppression regimen for over 4 weeks.

You may not be able to join if

  • I am pregnant or have a positive pregnancy test.
  • I have active heart failure or severe heart disease.
  • I have advanced bronchiolitis obliterans syndrome.
  • I had certain types of rejection in the last year.
  • I am using mechanical ventilation.
  • I have severe kidney disease.
  • I made recent changes to my immunosuppression therapy.
  • I have allergies to azithromycin.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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. The main question it aims to answer are: * Evaluate the effectiveness of ARINA-1 in preventing bronchiolitis obliterans syndrome (BOS) progression in participants with a bilateral lung transplant * To evaluate the effectiveness of ARINA-1 on improving…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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 …
Contacts

Carolyn Durham, PhD

919-240-7034

info@renovion.com

CONTACT

Will Anderson

919-240-7034

info@renovion.com

CONTACT