Using Metformin to Improve Kidney Health in FSGS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Praliciguat treatment for adults with focal segmental glomerulosclerosis (FSGS)

  This will test if praliciguat lowers urine protein in adults with biopsy-confirmed FSGS.

  Recruiting at 31 sites Phase 2 Akebia Therapeutics · Chula Vista, California and 31 other locations · NCT07268638

• BI 764198 for adults and adolescents with focal segmental glomerulosclerosis (FSGS).

  This study will test BI 764198 tablets taken once daily for up to two years in adults and adolescents with FSGS to see if it lowers urine protein and preserves kidney function.

  Recruiting at 253 sites Phase 3 Boehringer Ingelheim · Alabaster, Alabama and 314 other locations · NCT07220083

• Testing ManNAc for treating kidney disease FSGS

  This study is testing if a new oral treatment called ManNAc can help adults with kidney disease FSGS by reducing protein levels in their urine and checking how safe it is over 12 weeks.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06664814

• Evaluating treatments for kidney diseases in young to middle-aged adults

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• National Registry for Rare Kidney Diseases

  This study is collecting health information from people with rare kidney diseases to help improve treatments and create better care guidelines.

  Recruiting UK Kidney Association · Bristol, South West · NCT06065852

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.