Actively Recruiting
AMPK-activation by Metformin in FSGS: AMP-FSGS
Led by Yale University · Updated on 2026-02-03
30
Participants Needed
2
Research Sites
202 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this study is to determine whether extended-release MF (in addition to standard of care (S-o-C)) is superior to placebo in reducing podocyte injury and promoting podocyte survival by 6-months in Focal Segmental Glomerulosclerosis (FSGS).
CONDITIONS
Official Title
AMPK-activation by Metformin in FSGS: AMP-FSGS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and available for study duration
- Male or female, aged 18 to 80 years at consent
- Biopsy-confirmed primary FSGS with specific kidney pathology features
- Planned immunomodulatory treatment using glucocorticoids
- Able to take oral medication and willing to follow metformin or placebo regimen
- For females of reproductive potential: use of effective contraception before and during study, and for 12 weeks after
- For males of reproductive potential: use of condoms or effective contraception methods with partner
You will not qualify if you...
- Liver disease including cirrhosis, acute hepatitis, or related complications
- Estimated glomerular filtration rate (eGFR) less than 32 ml/min
- Diagnosis of diabetes mellitus at biopsy or need for insulin/oral hypoglycemics, or current metformin use
- Treatment with another investigational drug or intervention within past 3 months
- Current pregnancy or desire to become pregnant during study
- Unwillingness to use two forms of birth control for women of childbearing age
- Under hospice care
- Confirmed dementia diagnosis
- Incarceration or homelessness
- Unable to provide consent
- Participation in another investigational drug/device study within past 30 days
- Life expectancy under 6 months
- Allergy or sensitivity to metformin
- Low platelet count, bleeding disorders, or anticoagulant use contraindicating biopsy
- Use of carbonic anhydrase inhibitors
- Use of systemic immunosuppressive medication for non-renal reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Madhav C Menon, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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