[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523023":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":34,"locations":40,"responsibleParty":81,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":24,"studyType":100,"phases":101,"briefSummary":104,"conditions":105,"keywords":24,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin + Standard of Care","EXPERIMENTAL","Administration of daily oral extended-release Metformin 500 mg tablets with standard of care for 6 months.",[13],"Drug: Metformin + Standard of Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo + Standard of Care","PLACEBO_COMPARATOR","Administration of daily placebo tablets with standard of care for 6 months.",[19],"Other: Placebo + Standard of Care",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":6,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28,31],{"name":29,"affiliation":5,"role":30},"Madhav Menon, MD","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":30},"Cijiang He","Icahn School of Medicine at Mount Sinai",[35],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Madhav C Menon, MD","CONTACT","20373734507","madhav.menon@yale.edu",[41,63],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Yale New Haven Hospital","RECRUITING","New Haven","Connecticut","06510","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-72.92816,41.30815,{"lat":53,"lon":52},[56,58,61],{"name":57,"role":37,"phone":24,"phoneExt":24,"email":39},"Madhav Menon",{"name":59,"role":60,"phone":24,"phoneExt":24,"email":24},"Francis P Wilson, MD","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":24,"phoneExt":24,"email":24},"Randy Luciano, MD PhD",{"facility":64,"status":43,"city":65,"state":65,"zip":66,"country":47,"countryCode":48,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Mount Sinai Hospital","New York","10029",{"type":50,"coordinates":68},[69,70],-74.00597,40.71427,{"lat":70,"lon":69},[73,75,77,79],{"name":32,"role":37,"phone":24,"phoneExt":24,"email":74},"cijiang.he@mssm.edu",{"name":76,"role":60,"phone":24,"phoneExt":24,"email":24},"Joji Tokita",{"name":78,"role":60,"phone":24,"phoneExt":24,"email":24},"Kristin Meliambro",{"name":80,"role":60,"phone":24,"phoneExt":24,"email":24},"Jia Fu",{"type":82,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[84],{"name":85,"class":86},"United States Department of Defense","FED","100523023","phase-1-ampk-activation-by-metformin-in-fsgs-amp-fsgs-100523023",false,"NCT06090227","AMPK-activation by Metformin in FSGS: AMP-FSGS","AMP-FSGS","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged greater than or equal to 18 years, but \\\u003C\u002F= 80 years age at the time of signing the informed consent\n4. Biopsy-confirmed primary FSGS as defined by expert renal pathology at either institutions. For homogeneity of diagnoses, demonstrable segmental or global sclerosis lesions (\\>\u002F=1 glomerulus) with diffuse podocyte foot process effacement by electron microscopy (\\>\u002F+ 50% of examined glomerular tufts), or show evidence of mesangial expansion or mesangial sclerosis, also confirmed by electron microscopy.\n5. Therapeutic plan by treating physician for immunomodulatory treatment using Glucocorticoids.\n6. Ability to take oral medication and be willing to adhere to the MF or Placebo regimen\n7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 12 weeks after the end of VPA administration. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.\n\nExclusion Criteria:\n\n1. Liver disease: confirmed cirrhosis liver (any stage), acute hepatitis (\\> 2 fold increase in liver enzymes, any coagulopathy, hyperbilirubinemia, ascites or encephalopathy)\n2. estimated GFR \\\u003C 32 ml\u002Fmin\n3. Diabetes Mellitus diagnosis at the time of biopsy or need for oral hypoglycemic agents\u002FInsulin, or taking Metformin for other indications\n4. Treatment with another investigational drug or other intervention within 3 months\n5. Current pregnancy or desire to become pregnant during the study period\n6. Unwilling to use two forms of birth control (for women of childbearing age)\n7. Under hospice care\n8. Confirmed Dementia diagnoses in EMR problem list\n9. Incarceration\n10. Homelessness\n11. Inability to consent\n12. Currently enrolled in (or completed within the past 30 days) a study of an investigational drug or device.\n13. Life expectancy of less than 6 months as determined by the clinical judgement of the patient's primary physician\n14. Allergy or sensitivity to Metformin\n15. Platelet count \\\u003C 100,000\u002FµL; INR \\> 1.5; Bleeding diathesis or blood thinner use contraindicating biopsy.\n16. Bleeding diathesis or blood thinner use contraindicating biopsy will be excluded entirely from participation in research biopsy portion of study only, even if anticoagulation\u002Fblood thinners can be held temporarily.\n17. Simultaneous use of Carbonic anhydrase inhibitor agents\n18. Use of systemic immunosuppressive medication for non-renal indications","ALL","18 Years","80 Years",{"count":98,"type":99},30,"ESTIMATED","INTERVENTIONAL",[102,103],"PHASE1","PHASE2","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).",[106],"Focal Segmental Glomerulosclerosis","2026-01-30",{"date":109,"type":110},"2026-02-03","ACTUAL",{"date":112,"type":110},"2023-12-14",{"date":114,"type":99},"2027-11",{"name":5,"class":6},2]