Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05654922
PHASE3

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

Sponsor: Renovion, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

ARINA-1

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

OTHER

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