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RecruitingPhase 1Phase 2NCT06090227

AMPK-activation by Metformin in FSGS: AMP-FSGS

Sponsor

Yale University

Enrollment

30 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

Focal Segmental Glomerulosclerosis

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • 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.
  • Therapeutic plan by treating physician for immunomodulatory treatment using Glucocorticoids.
  • Ability to take oral medication and be willing to adhere to the MF or Placebo regimen
  • 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.

Exclusion Criteria18

  • 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
  • Current pregnancy or desire to become pregnant during the study period
  • Unwilling to use two forms of birth control (for women of childbearing age)
  • Under hospice care
  • Confirmed Dementia diagnoses in EMR problem list
  • Incarceration
  • Homelessness
  • Inability to consent
  • Currently enrolled in (or completed within the past 30 days) a study of an investigational drug or device.
  • Life expectancy of less than 6 months as determined by the clinical judgement of the patient's primary physician
  • Allergy or sensitivity to Metformin
  • Platelet count \< 100,000/µL; INR \> 1.5; Bleeding diathesis or blood thinner use contraindicating biopsy.
  • Bleeding diathesis or blood thinner use contraindicating biopsy will be excluded entirely from participation in research biopsy portion of study only, even if anticoagulation/blood thinners can be held temporarily.
  • Simultaneous use of Carbonic anhydrase inhibitor agents
  • Use of systemic immunosuppressive medication for non-renal indications
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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 Hospital

New Haven, Connecticut, United States

Mount Sinai Hospital

New York, New York, United States

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NCT06090227

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