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Immunomodulator
ARINA-1 for Bronchiolitis Obliterans Syndrome
Phase 3
Recruiting
Led By Ramsey Hachem, MD
Research Sponsored by Renovion, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-75 years old at the time of consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
Study Summary
This trial compares the effectiveness of a new drug to the existing standard of care for lung transplant recipients to see if it can improve quality of life and prevent or delay the need for additional treatment.
Who is the study for?
This trial is for adults aged 18-75 who've had a bilateral lung transplant over a year ago and are experiencing a decline in lung function. They must be on stable medications, including azithromycin and immunosuppressants, willing to follow the study schedule, and women of childbearing age must use birth control. Exclusions include recent use of certain therapies or supplements, unresolved lung damage, severe heart or kidney disease, participation in other trials recently, and specific treatments within set timeframes.Check my eligibility
What is being tested?
The trial tests ARINA-1 combined with standard care against standard care alone to see if it can prevent worsening of bronchiolitis obliterans syndrome (BOS) after lung transplants. It also looks at whether ARINA-1 helps maintain quality of life by reducing the need for increased immunosuppression therapy.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include typical reactions related to new medications such as gastrointestinal issues, allergic reactions or skin rashes. Participants will have regular clinic visits and phone calls to monitor any adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage change from baseline in FEV1 (%ΔFEV1)
Secondary outcome measures
Change from baseline in Saint George's Respiratory Questionnaire total score
Number of participants in each arm with augmented immunosuppression
Percentage change from baseline of FEF25-75%
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Standard of care onlyExperimental Treatment1 Intervention
Standard 3-therapy immunosuppression regimen and azithromycin
Group II: ARINA-1 plus standard of careExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARINA-1
2022
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Renovion, Inc.Lead Sponsor
2 Previous Clinical Trials
65 Total Patients Enrolled
Ramsey Hachem, MDPrincipal InvestigatorBarnes-Jewish Hospital / Washington University
2 Previous Clinical Trials
366 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a lung transplant more than a year ago.I was diagnosed with ARAD less than 6 weeks ago.I agree to use birth control during the study.I have severe heart failure or coronary artery disease.I started taking supplements with vitamin C, glutathione, or N-acetylcysteine less than 90 days ago.I have advanced kidney disease or am on dialysis.I was diagnosed with a weak windpipe less than 3 months ago.My lung function has significantly decreased after my transplant.I am between 18 and 75 years old.I am able to understand and agree to the study's procedures and risks.I have had a bronchial stent or cryotherapy in the last year.I am currently taking an mTOR inhibitor or azathioprine.I have used belatacept within the last 6 months.I have been taking azithromycin regularly for more than 4 weeks.I haven't used anti-thymocyte therapies or photopheresis in the last 90 days, but I've been on a stable dose of Trikafta for over 90 days.I haven't started or changed any antibiotic, antiviral, or antifungal treatment in the last 14 days.I have ongoing lung damage that has not healed.I was diagnosed with probable AMR less than a year ago.You have had an allergic reaction to azithromycin in the past.My lung scans show signs consistent with restrictive allograft syndrome.You are pregnant, as confirmed by a urine test.I have donor-specific antibodies identified less than 6 months ago.I started or changed my maintenance therapy less than 14 days ago.You are using a ventilator.I have not used alemtuzumab in the last 6 months.Your lung function has decreased by 10-24% in the past year after a lung transplant.I have been on a stable 3-drug immune system suppression plan for over 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: ARINA-1 plus standard of care
- Group 2: Standard of care only
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research accommodate individuals aged 45 and older?
"The minimum requirement to be part of this trial is 18 years and the maximum age limit set by investigators is 75."
Answered by AI
To whom is the opportunity to join this experiment open?
"This clinical trial is seeking 100 individuals who have been diagnosed with pre-bronchiolitis obliterans syndrome and are aged between 18 to 75."
Answered by AI
Has the ARINA-1 plus standard of care regimen received authorization from the FDA?
"Taking into consideration the data from its Phase 3 clinical trial, our team at Power has assigned ARINA-1 plus standard of care a safety rating of 3. This signifies that there is evidence to support both efficacy and multiple rounds' worth of safety information."
Answered by AI
What is the upper limit of participants in this trial?
"Affirmative. The records on clinicaltrials.gov indicate that this study, which was published on December 1st 2022, is actively looking for enrollees. Approximately 100 individuals are needed from two locations to complete the trial."
Answered by AI
Can individuals currently enroll in this research initiative?
"Affirmative. Clinicaltrials.gov states that this clinical trial is actively enrolling participants, with the original posting dated December 1st 2022 and latest update occurring on December 8th of the same year. The research necessitates 100 patients from 2 separate medical centres to participate in the study."
Answered by AI
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