AMPK-activation by Metformin in FSGS: AMP-FSGS

ConditionFocal Segmental Glomerulosclerosis

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorYale University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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 process effacement by electron microscopy (>/+ 50% of examined glomerular tufts), or show evidence of mesangial expansion or mesangial sclerosis, also confirmed by electron microscopy.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Metformin + Standard of Care
Drug
Administration of daily oral extended-release Metformin 500 mg tablets with standard of care for 6 months.
Placebo + Standard of Care
Other intervention
Administration of daily placebo tablets with standard of care for 6 months.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Metformin + Standard of CareExperimental treatment 1 intervention

Group B: Placebo + Standard of CarePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Slope of urinary NPHS2:Creatinine ratio

Measure of podocinuria via evaluation of urine podocin mRNA(nphs2) (measured as number of molecules detected by qPCR in the collected urine pellet) over the creatinine concentration. Intended for evaluation of efficacy of metformin versus placebo.

Time frame

6 months following randomization

Secondary outcomes

estimated Glomerular Filtration Rate (eGFR)

Calculated from serum creatinine (mg/dl) using the CKD-EPI formula. Intended for evaluation of efficacy of metformin versus placebo.

Time frame

6 months post-randomization

Slope of eGFR

Change in eGFR from randomization to 6 months by incorporating eGFR at all timepoints in study between baseline and 6 months post-randomization. eGFR calculated from serum creatinine (mg/dl) using the CKD-EPI formula. Intended for evaluation of efficacy of metformin versus placebo.

Time frame

6 months post-randomization

Urine protein:creatinine ratio

Calculated ratio of urine protein and creatinine, each collected from the electronic medical record. Intended for evaluation of clinical efficacy of metformin versus placebo.

Time frame

6 months post-randomization

Slope of urine protein:creatinine ratio

Change in urine protein:creatinine ratio from randomization to 6 months by incorporating urine protein:creatinine ratio at all timepoints in study between baseline and 6 months post-randomization. Intended for evaluation of clinical efficacy of metformin versus placebo.

Time frame

6 months post-randomization

Other outcomes

Body Mass Index (BMI)

Measured in kg/m2. Exploratory outcome intended for evaluation of adverse effects of metformin versus placebo.

Time frame

3 months post-randomization

Body Mass Index (BMI)

Measured in kg/m2. Exploratory outcome intended for evaluation of adverse effects of metformin versus placebo.

Time frame

6 months post-randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov

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