CClinicalTrials.gg
RecruitingNCT05654922Updated Aug 5, 2026

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

A Phase 3 interventional study of ARINA-1 and Standard of care only in Pre-Bronchiolitis Obliterans Syndrome, sponsored by Renovion, Inc.. Recruiting at 22 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Renovion, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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 quality of life decline and preventing or delaying the use of augmented immunosuppression in participants with pre-BOS relative to SOC.

Participants will have clinic visits at screening, randomization (day 1) and weeks 4, 12, 18, and 24. After week 24, participants will have clinic visits at weeks 32, 40, and 48.

Participants will also have a telehealth visit on day 2 and phone calls to assess adverse events (AEs), serious adverse events (SAEs), and review patient education will occur during weeks 5, 8, 36, and 44.

02

Conditions studied

  • Pre-Bronchiolitis Obliterans Syndrome
03

In context

Lead sponsor

Renovion, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    ARINA-1 plus standard of care

    ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH); fixed dose, 4 mL solution inhaled twice daily via nebulization plus standard 3-therapy immunosuppression regimen and azithromycin

    Drug: ARINA-1

  • Other
    Standard of care only

    Standard 3-therapy immunosuppression regimen and azithromycin

    Other: Standard of care only

Interventions

  • DrugARINA-1

    ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH)

  • OtherStandard of care only

    Standard 3-therapy immunosuppression regimen and azithromycin

06

What researchers measure

Primary outcomes

  1. Percentage change from baseline in FEV1 (%ΔFEV1)

    Week 24 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1

    Time frame: 24 weeks

Secondary outcomes

  1. Percentage change from baseline of Forced Expiratory Volume in one second (FEV1)

    Week 48 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1

    Time frame: 48 weeks

  2. Percentage change from baseline of Forced Vital Capacity (FVC)

    Time frame: 24 weeks

  3. Percentage change from baseline of FVC

    Time frame: 48 weeks

  4. Percentage change from baseline of FEF25-75%

    Time frame: 24 weeks

  5. Percentage change from baseline of FEF25-75%

    Time frame: 48 weeks

  6. Number of participants in each arm with augmented immunosuppression

    number

    Time frame: 24 weeks

  7. Number of participants in each arm with augmented immunosuppression

    Time frame: 48 weeks

  8. Time to initiation of augmented immunosuppression

    Length of time to when participant requires a change in their immunosuppression regimen

    Time frame: over the duration of the 48 week trial

  9. Change from baseline in Saint George's Respiratory Questionnaire total score

    quality of life questionnaire, total score of 0 to 100, higher score = more limitations

    Time frame: 24 weeks

  10. Change from baseline in Saint George's Respiratory Questionnaire total score

    quality of life questionnaire, total score of 0 to 100, higher score = more limitations

    Time frame: 48 weeks

  11. Proportion of participants requiring the use of antimicrobial agents to treat a pulmonary infection

    Time frame: 48 weeks

07

Study locations

18 of 22 sites recruiting
  • Dignity Health - St. Joseph's Hospital and Medical Center
    Phoenix, Arizona 85013, United States
    Withdrawn
  • University of California Los Angeles School of Medicine
    Los Angeles, California 90095, United States
    • Sam Weigt, MD · Principal investigator
    Recruiting
  • University of California San Diego Health
    San Diego, California 92103, United States
    • Kamyar Afshar, MD · Principal investigator
    Recruiting
  • Advent Health
    Orlando, Florida 32803, United States
    • Suresh Manickavel, MD · Principal investigator
    Recruiting
  • University of South Florida
    Tampa, Florida 33606, United States
    • Satish Chandrashekaran, MD · Principal investigator
    Recruiting
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
    • Daniel Dilling, MD · Principal investigator
    Recruiting
  • University of Iowa Hospital
    Iowa City, Iowa 52242, United States
    • Julia Klesney-Tait, MD, PhD · Principal investigator
    Recruiting
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
    • Christian Merlo, MD · Principal investigator
    Recruiting
  • University of Minnesota Medical School
    Minneapolis, Minnesota 55455, United States
    Withdrawn
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    • Yuka Yuka Furuya, MD · Principal investigator
    Not yet recruiting
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    • Chad Witt, MD · Principal investigator
    Recruiting
  • Columbia University Irving Medical Center
    New York, New York 10032, United States
    • Selim Arcasoy, MD · Principal investigator
    Recruiting
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
    • Marie Budev, DO · Principal investigator
    Recruiting
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43221, United States
    • Justin Rosenheck, DO · Principal investigator
    Recruiting
  • Temple University Hospital
    Philadelphia, Pennsylvania 19122, United States
    • Rachel Criner, MD · Principal investigator
    Recruiting
  • Medical University of South Carolina
    Charleston, South Carolina 29452, United States
    • Tim Whelan, MD · Principal investigator
    Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
    • Ciara Shaver, MD, PhD · Principal investigator
    Not yet recruiting
  • University of Texas Southwestern Medical Center
    Dallas, Texas 45390, United States
    • Vaidehi Kaza, MD · Principal investigator
    Recruiting
  • Baylor Scott and White Research Institute
    Dallas, Texas 75246, United States
    • Samir Kumar, MD · Principal investigator
    Recruiting
  • Baylor St. Luke's Medical Center
    Houston, Texas 77030, United States
    • Prangthip Charoenpong, MD, MPH · Principal investigator
    Recruiting
  • Houston Methodist Hospital
    Houston, Texas 77030, United States
    • Howard Huang, MD · Principal investigator
    Recruiting
  • Inova Fairfax Hospital
    Falls Church, Virginia 22042, United States
    • Shambhu Aryal, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05654922
Lead sponsor
Renovion, Inc.
Responsible party
Sponsor
First posted
Dec 16, 2022
Start date
Apr 10, 2023
Primary completion
Feb 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Aug 5, 2026

Study contacts

Carolyn Durham, PhD
Contact
info@renovion.com
919-240-7034
Will Anderson
Contact
info@renovion.com
919-240-7034
Tim Whelan, MD
principal investigator · Medical University of South Carolina

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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