AMPK-activation by Metformin in FSGS: AMP-FSGS

ID#: NCT06090227

Age: 18 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: December 14, 2023

End Date: November 01, 2027

Contact Information:
Madhav C Menon, MD
20373734507
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:

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
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.
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