Evaluating ARINA-1 for preventing lung transplant complications

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 Phase 3 clinical trial aims to assess the effectiveness of ARINA-1, a nebulized immunomodulatory agent, in preventing the progression of bronchiolitis obliterans syndrome (BOS) in patients who have undergone bilateral lung transplants. Participants will receive either ARINA-1 in addition to standard care or standard care alone, with evaluations occurring at multiple clinic visits over 48 weeks. The study will also monitor quality of life and the need for increased immunosuppression. Telehealth visits and phone calls will be used to track adverse events and provide patient education.

Why it matters

Who can join: the full rules

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 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:

1. Positive urine pregnancy test at screening and baseline visit
2. Diagnosis of active congestive heart failure or symptomatic coronary artery disease \> grade 3 based on the New York Heart Association Functional Classification (NYHA) criteria
3. Restrictive allograft syndrome (RAS) defined by radiographic interstitial or alveolar opacities on chest X-ray or CT scan that are consistent with RAS
4. Have advanced BOS, defined by \>24% decrease in FEV1 in post-transplant baseline
5. A diagnosis of probable antibody-mediated rejection (AMR) \<12 months prior to the baseline visit
6. Donor-specific antibodies (DSA) identified \<6 months prior to the baseline visit. \*The presence of DSA \>6 months from the baseline visit is acceptable for enrollment into the study.
7. Unresolved diffuse alveolar damage
8. Receiving mechanical ventilation
9. Chronic kidney disease stage IV or higher, including on dialysis
10. Initiating a new maintenance therapy or changing immunosuppression maintenance therapy (e.g., changing tacrolimus to cyclosporine) \<30 days prior to the baseline visit.
11. Have initiated or changed mTOR maintenance therapy \<3 months prior to Clinic Visit 1 (mTOR use for \>3 months is allowed)
12. Initiating or changing antibiotic (including azithromycin), antiviral, or antifungal therapy \<14 days prior to the baseline visit.
13. Use of alemtuzumab \<6 months prior to the baseline visit
14. Use of anti-thymocyte therapies (e.g., anti-thymocyte globulin) or photopheresis \<90 days prior to the Screening Visit. Prior use of Trikafta (elexacaftor, ivacaftor, and tezacaftor is allowed as long as the participant has been on stable dose for \>90 days prior to the Screening Visit.
15. Initiating a multivitamin or other supplement (inhaled, oral, or IV) containing vitamin C, glutathione, or N-acetylcysteine \<90 days prior to the baseline visit
16. Significant unstable comorbidities, in the opinion of the site investigator
17. Allery or previous adverse reaction to azithromycin
18. A diagnosis of dynamic collapse / tracheobrochomalacia \<90 days of the baseline visit.
19. Subjects currently participating in, or who have participated in an interventional (drug or device) clinical study \<30 days of the baseline visit.
20. Have been diagnosed with ARAD within 6 weeks of the Screening Visit.
21. Have used belatacept \<6 months prior to Clinic Visit 1
22. Have had an initial treatment of bronchial stents or cryotherapy within 12 months of the Screening Visit, or had bronchial stents removed within the last 3 months of the Screening Visit.

Where it's running

• University of California Los Angeles School of Medicine
  Los Angeles, California, United States Recruiting
• University of California San Diego Health
  San Diego, California, United States Recruiting
• Advent Health
  Orlando, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Loyola University Medical Center
  Maywood, Illinois, United States Recruiting
• University of Iowa Hospital
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Tim Whelan, MD — Medical University of South Carolina
• Study coordinator: Carolyn Durham, PhD
• Email: info@renovion.com
• Phone: 919-240-7034

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Investigating abnormal cells in patients with bronchiolitis obliterans syndrome

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• Long-term observation of lung injury in children after stem cell transplants

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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.