AMPK-activation by Metformin in FSGS: AMP-FSGS

Description

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).

Conditions

Focal Segmental Glomerulosclerosis

Study Overview

Study Details

Study overview

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).

AMPK-activation by Metformin in FSGS: AMP-FSGS

AMPK-activation by Metformin in FSGS: AMP-FSGS

Condition
Focal Segmental Glomerulosclerosis
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06510

New York

Mount Sinai Hospital, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • 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 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.
  • 1. Liver disease: confirmed cirrhosis liver (any stage), acute hepatitis (\> 2 fold increase in liver enzymes, any coagulopathy, hyperbilirubinemia, ascites or encephalopathy)
  • 2. estimated GFR \< 32 ml/min
  • 3. Diabetes Mellitus diagnosis at the time of biopsy or need for oral hypoglycemic agents/Insulin, or taking Metformin for other indications
  • 4. Treatment with another investigational drug or other intervention within 3 months
  • 5. Current pregnancy or desire to become pregnant during the study period
  • 6. Unwilling to use two forms of birth control (for women of childbearing age)
  • 7. Under hospice care
  • 8. Confirmed Dementia diagnoses in EMR problem list
  • 9. Incarceration
  • 10. Homelessness
  • 11. Inability to consent
  • 12. Currently enrolled in (or completed within the past 30 days) a study of an investigational drug or device.
  • 13. Life expectancy of less than 6 months as determined by the clinical judgement of the patient's primary physician
  • 14. Allergy or sensitivity to Metformin
  • 15. Platelet count \< 100,000/µL; INR \> 1.5; Bleeding diathesis or blood thinner use contraindicating biopsy.
  • 16. Simultaneous use of Carbonic anhydrase inhibitor agents
  • 17. Use of systemic immunosuppressive medication for non-renal indications.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Madhav Menon, MD, PRINCIPAL_INVESTIGATOR, Yale University

Cijiang He, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2027-11