Overview

AMPK-activation by Metformin in FSGS: AMP-FSGS

Status:
Recruiting

Trial end date:
2027-11-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yale University

Collaborator:

United States Department of Defense

Treatments:

Metformin

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 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.

Exclusion Criteria:

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.