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
N/A
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
Researchers are investigating the use of extended-release Metformin (MF) alongside standard treatments to reduce podocyte injury and support podocyte survival in people with Focal Segmental Glomerulosclerosis (FSGS), a kidney disease that can lead to end-stage kidney disease. FSGS involves damage to specialized kidney cells called podocytes, which are vital for kidney function. This study aims to evaluate whether Metformin can improve podocyte health compared to a placebo over six months. Participants will be randomly assigned to receive either daily oral extended-release Metformin 500 mg tablets plus standard care or daily placebo tablets plus standard care for six months. Standard care includes immune-modulating treatments like corticosteroids and blood pressure management. The study includes a triple-blind design to ensure unbiased results. Researchers will monitor the effects of Metformin on kidney cells using urine tests and kidney biopsies. During the study, participants will undergo assessments including blood and urine tests, kidney biopsies, and symptom questionnaires to evaluate kidney function, protein levels in urine, and possible side effects related to Metformin. The primary outcome measures focus on changes in urinary markers of podocyte injury over six months. Secondary outcomes will assess kidney filtration rates, proteinuria, quality of life, and safety indicators. The trial will last six months with ongoing monitoring and evaluation of kidney health and treatment safety.
CONDITIONS
Brief 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 be available for the study duration
- Male or female aged 18 to 80 years at time of consent
- Biopsy-confirmed primary FSGS with specific pathological features as defined by expert review
- Planned immunomodulatory treatment with glucocorticoids by treating physician
- Ability and willingness to take oral medication and follow Metformin or placebo regimen
- For females of reproductive potential: use of effective contraception during and for 12 weeks after treatment; for males: use of condoms or other contraception methods
You will not qualify if you...
- Liver disease including cirrhosis, acute hepatitis, or related complications
- Estimated glomerular filtration rate below 32 ml/min
- Diagnosis of diabetes mellitus or current use of diabetes medications including Metformin
- Use of another investigational drug or intervention within 3 months
- Current pregnancy or desire to become pregnant during study
- Unwillingness to use two forms of birth control if female of childbearing age
- Under hospice care
- Confirmed dementia diagnosis
- Incarceration or homelessness
- Inability to provide informed consent
- Enrollment in another investigational drug or device study within past 30 days
- Life expectancy less than 6 months
- Allergy or sensitivity to Metformin
- Low platelet count, bleeding disorders, or use of blood thinners 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive daily oral extended-release Metformin 500 mg tablets or placebo in addition to standard of care for 6 months.
Regular visits for treatment monitoring and safety assessments
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
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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