NCT06090227 AMPK-activation by Metformin in FSGS: AMP-FSGS
| NCT ID | NCT06090227 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Yale University |
| Condition | Focal Segmental Glomerulosclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-12-14 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-12-14 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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), 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
Contact & Investigator
Madhav Menon, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06090227 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Focal Segmental Glomerulosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06090227 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06090227 currently recruiting?
Yes, NCT06090227 is actively recruiting participants. Contact the research team at madhav.menon@yale.edu for enrollment information.
Where is the NCT06090227 trial being conducted?
This trial is being conducted at New Haven, United States, New York, United States.
Who is sponsoring the NCT06090227 clinical trial?
NCT06090227 is sponsored by Yale University. The principal investigator is Madhav Menon, MD at Yale University. The trial plans to enroll 30 participants.