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AMPK-activation by Metformin in FSGS: AMP-FSGS

NCT06090227 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-03

No results posted yet for this study

Summary

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

  • Focal Segmental Glomerulosclerosis

Interventions

DRUG

Metformin + Standard of Care

Administration of daily oral extended-release Metformin 500 mg tablets with standard of care for 6 months.

OTHER

Placebo + Standard of Care

Administration of daily placebo tablets with standard of care for 6 months.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Yale University

    lead OTHER

Principal Investigators

  • Madhav Menon, MD · Yale University

  • Cijiang He · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06090227 on ClinicalTrials.gov