AMPK-activation by Metformin in FSGS: AMP-FSGS

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).

CT.gov Identifier

NCT06090227

EudraCT Identifier

N/A

CTIS:

N/A

Collaborator

(Other government agency)

Study Contact Information

N/A

Recruiting

Study Details

Diseases

Focal Segmental Glomerulosclerosis

Study Drug

Metformin, unspecified

Undisclosed - diuretic

Genes

N/A

Study Dates

Dec 2023 - Nov 2027

Sex

Female & Male

Age

18 - 80 Years

Inclusion and Exclusion 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
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), or show evidence of mesangial expansion or mesangial sclerosis, also confirmed by electron microscopy.
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. 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.
17. Simultaneous use of Carbonic anhydrase inhibitor agents
18. Use of systemic immunosuppressive medication for non-renal indications

Protocol Summary

Study Locations

To view all trial locations, click here

Contact Us About More Information for the Clinical Trial Concierge Service

Natera’s Clinical Trial Concierge Program is comprised of a dedicated team that helps connect providers and patients with appropriate clinical trials. To learn more about a trial offered through this service, please complete the form below.

Fields marked with asterisk (*) are mandatory.