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

Launched by RENOVION, INC. · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ARINA-1 to see if it can help prevent a condition called bronchiolitis obliterans syndrome (BOS) from getting worse in people who have received a lung transplant. Researchers want to find out if adding ARINA-1 to the usual care can improve patients' quality of life and reduce the need for stronger immune-suppressing medications. Participants in the study will have several visits to the clinic over a 48-week period to monitor their health and any side effects.

To join the trial, participants must be between 18 and 75 years old and have received a bilateral lung transplant more than a year ago. They should also have a slight decrease in lung function since their transplant. Participants will need to be stable on their current medications and able to attend all the scheduled visits. This trial is currently recruiting, so if this sounds like something you or a loved one might be interested in, it’s a good idea to talk to your healthcare provider for more information.

Gender

ALL

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 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 3-agent immunosuppression regimen that includes a steroid, a calcineurin inhibitor (CNI), and 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) \<14 days prior to the baseline visit.
• • 11. Currently using an mTOR inhibitor or azathioprine
• • 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 bronchial stents or cryotherapy within 12 months of the Screening Visit

Trial Officials