Using Metformin to Improve Kidney Health in FSGS
AMPK-activation by Metformin in FSGS: AMP-FSGS
This study is testing if taking extended-release Metformin along with regular treatment can help improve kidney health in people with Focal Segmental Glomerulosclerosis (FSGS).
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT06090227 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of extended-release Metformin in conjunction with standard care compared to a placebo in patients with Focal Segmental Glomerulosclerosis (FSGS). The primary goal is to reduce podocyte injury and enhance podocyte survival over a six-month period. FSGS is a serious kidney disease characterized by significant protein loss and podocyte damage, leading to chronic kidney disease and end-stage kidney disease. By targeting the mechanisms that promote podocyte survival, this study seeks to potentially alter the disease's progression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with biopsy-confirmed primary FSGS and a therapeutic plan involving glucocorticoids.
Not a fit: Patients with conditions other than primary FSGS or those who cannot comply with the study's medication regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve kidney function and quality of life for patients with FSGS.
How similar studies have performed: While the use of Metformin in kidney diseases is being explored, this specific approach targeting podocyte survival in FSGS is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / 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 \</= 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), 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
Where this trial is running
New Haven, Connecticut and 1 other locations
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Madhav Menon, MD — Yale University
- Study coordinator: Madhav C Menon, MD
- Email: madhav.menon@yale.edu
- Phone: 20373734507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.