Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT06090227
Eligibility 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 \</= 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.
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06090227
Study Brief:
Protocol Section:
NCT06090227