Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis
(MAVRIC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a randomized, placebo-controlled trial of metformin in 400 participants with idiopathic pulmonary fibrosis (IPF) who are at high risk of adverse clinical outcomes based on a proteomic classifier. The primary objective is to assess the safety and efficacy of metformin compared to placebo in participants with IPF who are at high-risk for adverse clinical events.
Approximately 800 participants with IPF will be screened. 400 participants who are at high risk for adverse clinical events (proteomic signature present) will be randomized into receiving metformin (n\~200) or matching placebo (n\~200). Participants that meet the eligibility criteria but do not have the proteomic signature (proteomic signature absent) will be contacted by phone at 12 and 24 months to review medical history.
Who Is on the Research Team?
Fernando Martinez, MD, MS
Principal Investigator
UMass Chan Medical School
Sydney Montesi, MD
Principal Investigator
Massachusetts General Hospital
Bhavika Kaul, MD, MAS
Principal Investigator
Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC)
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
200 participants who have a screening blood test result that is proteomic signature present will be randomized to oral metformin at a total target daily dose of 1500mg per day for 12 to 24 months depending on time of enrollment into the trial.
Participants that meet the eligibility criteria but do have a screening blood test result that is proteomic signature absent (about 400 participants) will be asked to attend 2 follow-up remote visits at 12 and 24 months. This arm will be observational only.
200 participants who have a screening blood test result that is proteomic signature present will be randomized to matching placebo 12 to 24 months depending on time of enrollment into the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Massachusetts, Worcester
Lead Sponsor
United States Department of Defense
Collaborator
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