AMPK-activation by Metformin in FSGS: AMP-FSGS
Trial Parameters
Brief 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).
Eligibility Criteria
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 glomerular tufts), or show evidence of mesangial expansion or mesangial sclerosis, also confirmed by electron microscopy. 5. Therapeutic plan by treating physician for immunomodulatory treatment using Glucocorticoids. 6. Ability to take oral medication and be willing to adhere to the MF or Placebo regimen 7. For females of reproductive potential: use of highly effective contraception for at least 1 month pr