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New treatment option for Focal Segmental Glomerulosclerosis
Official title AMPK-activation by Metformin in FSGS: AMP-FSGS
ClinicalTrials.gov ID: NCT06090227
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged greater than or equal to 18 years, but \</= 80 years age at the time of signing the informed consent
- Biopsy-confirmed primary FSGS as defined by expert renal pathology at either institutions. For homogeneity of diagnoses, demonstrable segmental or...
- Therapeutic plan by treating physician for immunomodulatory treatment using Glucocorticoids.
You likely can't join if
- Liver disease: confirmed cirrhosis liver (any stage), acute hepatitis (\> 2 fold increase in liver enzymes, any coagulopathy, hyperbilirubinemia...
- estimated GFR \< 32 ml/min
- Diabetes Mellitus diagnosis at the time of biopsy or need for oral hypoglycemic agents/Insulin, or taking Metformin for other indications
- Treatment with another investigational drug or other intervention within 3 months
- Current pregnancy or desire to become pregnant during the study period
- Unwilling to use two forms of birth control (for women of childbearing age)
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged greater than or equal to 18 years, but \</= 80 years age at the time of signing the informed consent
- 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...
- Therapeutic plan by treating physician for immunomodulatory treatment using Glucocorticoids.
- Ability to take oral medication and be willing to adhere to the MF or Placebo regimen
- 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...
- Liver disease: confirmed cirrhosis liver (any stage), acute hepatitis (\> 2 fold increase in liver enzymes, any coagulopathy, hyperbilirubinemia, ascites or encephalopathy)
- estimated GFR \< 32 ml/min
- Diabetes Mellitus diagnosis at the time of biopsy or need for oral hypoglycemic agents/Insulin, or taking Metformin for other indications
- Treatment with another investigational drug or other intervention within 3 months
- Current pregnancy or desire to become pregnant during the study period
- Unwilling to use two forms of birth control (for women of childbearing age)
- Under hospice care
- Confirmed Dementia diagnoses in EMR problem list
- Incarceration
- Homelessness
- Inability to consent
- Currently enrolled in (or completed within the past 30 days) a study of an investigational drug or device.
- Life expectancy of less than 6 months as determined by the clinical judgement of the patient's primary physician
- Allergy or sensitivity to Metformin
- Platelet count \ 1.5; Bleeding diathesis or blood thinner use contraindicating biopsy.
- 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.
- Simultaneous use of Carbonic anhydrase inhibitor agents
- Use of systemic immunosuppressive medication for non-renal indications
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.