AMPK-activation by Metformin in FSGS: AMP-FSGS
ConditionFocal Segmental Glomerulosclerosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYale University
About this trial
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
Qualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged greater than or equal to 18 years, but </= 80 years age at the time of signing the informed consent
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.
Disqualifiers
Liver disease: confirmed cirrhosis liver (any stage), acute hepatitis (> 2 fold increase in liver enzymes, any coagulopathy, hyperbilirubinemia, ascites or encephalopathy)
estimated GFR < 32 ml/min
Diabetes Mellitus diagnosis at the time of biopsy or need for oral hypoglycemic agents/Insulin, or taking Metformin for other indications
Treatment with another investigational drug or other intervention within 3 months
Trial design
Treatments tested in this trial
- Metformin + Standard of Care
- Placebo + Standard of Care
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov