AMPK-activation by Metformin in FSGS: AMP-FSGS

Launched by YALE UNIVERSITY · Oct 13, 2023

Keywords

ClinConnect Summary

The AMPK-activation by Metformin in FSGS trial, also known as the AMP-FSGS study, is looking at whether a medication called metformin can help protect kidney cells in patients with a condition called Focal Segmental Glomerulosclerosis (FSGS). This study will compare the effects of metformin, given along with standard treatment, to a placebo (a dummy treatment that doesn't contain the active drug) over a period of six months. The main goal is to see if metformin can reduce damage to kidney cells and help them survive better.

To participate in this study, individuals must be between 18 and 80 years old, have a confirmed diagnosis of FSGS, and be able to take oral medications. Participants will need to follow certain guidelines, such as using effective birth control if they are of reproductive age and being willing to attend regular study visits. This study is currently recruiting participants, and it's a great opportunity for those with FSGS to potentially benefit from a new treatment approach while contributing to important research.

Gender

ALL

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.