AMPK-activation by Metformin in FSGS: AMP-FSGS
Yale University
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).
Description
Focal Segmental glomerulosclerosis (FSGS) is currently the most common primary glomerular disease that progresses to ESKD in the US. FSGS is typified by significant proteinuria, and by disorganization of the actin cytoskeleton of highly specialized epithelial cells which support the glomerular capillary loop called podocytes. Podocytes are characterized by foot processes, whose disorganization with injury is visualized on electron microscopy as foot process effacement (FPE). Podocytes are also incapable of self-renewal, and podocyte loss over \~40% per glomerulus leads to proteinuria, the neph…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged greater than or equal to 18 years, but \</= 80 years age at the time of signing the informed consent 4. Biopsy-confirmed primary FSGS as defined by expert renal pathology at either institutions. For homogeneity of diagnoses, demonstrable segmental or global sclerosis lesions (\>/=1 glomerulus) with diffuse podocyte foot process effacement by electron microscopy (\>/+ 50% of examined glomerula…
Interventions
- DrugMetformin + Standard of Care
Administration of daily oral extended-release Metformin 500 mg tablets with standard of care for 6 months.
- OtherPlacebo + Standard of Care
Administration of daily placebo tablets with standard of care for 6 months.
Locations (2)
- Yale New Haven HospitalNew Haven, Connecticut
- Mount Sinai HospitalNew York, New York