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Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant
Sponsor: Renovion, Inc.
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.
Official title: A Phase 3, Open-label, Randomized, Standard of Care-controlled, Parallel Study Arm Study to Demonstrate Efficacy and Safety of ARINA-1 in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) Progression in Participants With a Bilateral Lung Transplant
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-04-10
Completion Date
2026-11
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
ARINA-1
ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH)
Standard of care only
Standard 3-therapy immunosuppression regimen and azithromycin
Locations (20)
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
University of California Los Angeles School of Medicine
Los Angeles, California, United States
University of California San Diego Health
San Diego, California, United States
Advent Health
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Iowa Hospital
Iowa City, Iowa, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Irving Medical Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor Scott and White Research Institute
Dallas, Texas, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States