Metformin for Focal Segmental Glomerulosclerosis (FSGS)

This study is looking at whether Metformin, a medication, can help people with Focal Segmental Glomerulosclerosis (FSGS). FSGS is a kidney disease where the filtering units (glomeruli) become scarred, which can lead to kidney failure. Researchers want to see if taking Metformin along with your usual care is better than a placebo (an inactive pill) and usual care. They will measure changes in a specific marker in your urine (NPHS2:Creatinine ratio) after 6 months to see if Metformin helps protect the kidney cells called podocytes. The study aims to enroll 30 participants aged 18 to 80 who have been diagnosed with FSGS through a kidney biopsy. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 30 participants. Participants will be randomly assigned to receive either Metformin or a placebo, both in addition to their standard medical care.
What's involved
Participants will take daily oral tablets for 6 months. The primary measurement will be taken at 6 months after starting the study treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 6 months following randomization, indicating a follow-up period of at least 6 months.

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NCT06090227

AMPK-activation by Metformin in FSGS: AMP-FSGS

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Yale University
~30 participants
Updated 2026-02-03 on ClinicalTrials.gov
What's tested:Metformin + Standard of CarePlacebo + Standard of Care

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Slope of urinary NPHS2:Creatinine ratio
Measured over 6 months following randomization
Focal Segmental Glomerulosclerosis
2 sites across 2 states
Connecticut1
New York1
  • Madhav Menon, MD · PRINCIPAL_INVESTIGATOR · Yale University
  • Cijiang He · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

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  • Slope of urinary NPHS2:Creatinine ratio6 months following randomization

    Measure of podocinuria via evaluation of urine podocin mRNA(nphs2) (measured as number of molecules detected by qPCR in the collected urine pellet) over the creatinine concentration. Intended for evaluation of efficacy of metformin versus placebo.