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

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ClinicalTrials.gov Identifier: NCT05654922
Recruitment Status : Recruiting
First Posted : December 16, 2022
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Renovion, Inc.

Study Description
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Brief Summary:

The goal of this clinical trial is to compare ARINA-1 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.


Condition or disease Intervention/treatment Phase
Pre-Bronchiolitis Obliterans Syndrome Drug: ARINA-1 Other: Standard of care only Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: For individuals performing spirometry, every attempt will be made to keep them masked to treatment.
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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
 Other: Standard of care only
Standard 3-therapy immunosuppression regimen and azithromycin


Outcome Measures
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Primary Outcome Measures :
  1. Percentage change from baseline in FEV1 (%ΔFEV1) [ Time Frame: 24 weeks ]
    Week 24 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1


Secondary Outcome Measures :
  1. Percentage change from baseline of Forced Expiratory Volume in one second (FEV1) [ Time Frame: 48 weeks ]
    Week 48 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1

  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 [ Time Frame: 24 weeks ]
    number

  7. Number of participants in each arm with augmented immunosuppression [ Time Frame: 48 weeks ]
  8. Time to initiation of augmented immunosuppression [ Time Frame: over the duration of the 48 week trial ]
    Length of time to when participant requires a change in their immunosuppression regimen

  9. Change from baseline in Saint George's Respiratory Questionnaire total score [ Time Frame: 24 weeks ]
    quality of life questionnaire, total score of 0 to 100, higher score = more limitations

  10. Change from baseline in Saint George's Respiratory Questionnaire total score [ Time Frame: 48 weeks ]
    quality of life questionnaire, total score of 0 to 100, higher score = more limitations


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 10-20% 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 Screening
  8. On a stable 3-agent immunosuppression regimen that includes a steroid, a calcineurin inhibitor (CNI), and cell cycle inhibitor (e.g., mycophenolate) >4 weeks prior to Screening

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. Advanced BOS (BOS 1-4) defined by >20% 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. 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 baseline 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 or endobronchial stent <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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05654922


Contacts
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Contact: Carolyn Durham, PhD 919-240-7034 info@renovion.com

Locations
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United States, California
University of California Los Angeles (UCLA) Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Paul Lopez    310-794-8595    PLopez@mednet.ucla.edu   
University of California at San Diego Not yet recruiting
San Diego, California, United States, 92103
Contact: Amber Martineua    619-471-0817    ajm002@health.ucsd.edu   
United States, Florida
University of South Florida - Tampa General Hospital Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Kilhaun Robinson    813-844-8845    krobinson@tgh.org   
United States, Iowa
University of Iowa Hospitals and Clinics Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Lindsey Reinhardt    319-384-7547    lindsey-reinhardt@uiowa.edu   
United States, Maryland
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Shivani Patel       spate156@jhmi.edu   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Brigitte Mittler    314-747-1931    b.mittler@wustl.edu   
United States, New York
Columbia University Not yet recruiting
New York, New York, United States, 10032
Contact: Leonor Suarez       ls955@cuimc.columbia.edu   
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Joanne Baran-Smiley    216-444-5023    baranj2@ccf.org   
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Brent Oleksak    614-366-2775    brent.oleksak@osumc.edu   
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Angela Millare    843-792-3710    millare@musc.edu   
United States, Texas
Houston Methodist Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Aisha Matin    281-414-9916    amatin@houstonmethodist.org   
Sponsors and Collaborators
Renovion, Inc.
More Information
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Responsible Party: Renovion, Inc.
ClinicalTrials.gov Identifier: NCT05654922    
Other Study ID Numbers: RVN-001
First Posted: December 16, 2022    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchiolitis
Bronchiolitis Obliterans
Syndrome
Disease
Pathologic Processes
Bronchitis
 Respiratory Tract Infections
Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases