← Back to Search

Anti-diabetic agent

Metformin for FSGS (AMP-FSGS Trial)

Phase 1 & 2
Recruiting
Led By Cijiang He
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged greater than or equal to 18 years, but </= 80 years age at the time of signing the informed consent
Ability to take oral medication and be willing to adhere to the MF or Placebo regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-randomization
Awards & highlights

AMP-FSGS Trial Summary

This trial studies if a drug can help protect podocytes in people with FSGS, a kidney disease.

Who is the study for?
This trial is for adults aged 18-80 with biopsy-confirmed primary FSGS who can take oral medication and follow the study procedures. Participants must use effective contraception, have a plan for immunomodulatory treatment, and not have liver disease, severe kidney impairment, diabetes requiring medication, or be pregnant. They shouldn't be on other investigational drugs or treatments.Check my eligibility
What is being tested?
The AMP-FSGS trial is testing if extended-release Metformin plus standard care is better than placebo at reducing podocyte injury in FSGS patients over six months. The goal is to see if Metformin helps podocytes survive better than usual treatments alone.See study design
What are the potential side effects?
Metformin may cause side effects like digestive issues (nausea, diarrhea), potential vitamin B12 deficiency with long-term use, and rarely lactic acidosis—a serious metabolic complication that requires immediate medical attention.

AMP-FSGS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old.
Select...
I can take pills and will follow the treatment plan.
Select...
My kidney disease diagnosis was confirmed by a biopsy showing specific damage.

AMP-FSGS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Slope of urinary NPHS2:Creatinine ratio
Secondary outcome measures
Complete or partial remission
Complete remission
Discontinuation of study drug
+23 more
Other outcome measures
Body Mass Index (BMI)

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

AMP-FSGS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Metformin + Standard of CareExperimental Treatment1 Intervention
Administration of daily oral extended-release Metformin 500 mg tablets with standard of care for 6 months.
Group II: Placebo + Standard of CarePlacebo Group1 Intervention
Administration of daily placebo tablets with standard of care for 6 months.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
865 Previous Clinical Trials
327,669 Total Patients Enrolled
Yale UniversityLead Sponsor
1,853 Previous Clinical Trials
2,738,531 Total Patients Enrolled
Cijiang HePrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open to individuals who are over two decades old?

"Eligibility requirements for this study are that participants must be 18+ and under 80 years of age."

Answered by AI

Is registration for this trial open at the moment?

"According to the information available on clinicaltrials.gov, this particular study is no longer recruiting patients as it was last updated in October of 2023. Fortunately, there are 14 other trials currently accepting participants for their respective studies."

Answered by AI

What population is eligible to participate in this trial?

"This medical trial is actively seeking 30 patients aged 18 to 80 with focal segmental glomerulosclerosis. Necessary criteria include providing a signed and dated informed consent form, using highly effective contraception for females of reproductive potential prior to screening, stated willingness to comply with all study procedures, biopsy-confirmed primary FSGS as defined by expert renal pathology (at least 1 glomerulus exhibiting diffuse podocyte foot process effacement), therapeutic plan involving immunomodulatory treatment using glucocorticoids, the ability to take oral medication and adhere to the MF or placebo regimen."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
AMPK-activation by Metformin in FSGS: AMP-FSGS
2023. "AMPK-activation by Metformin in FSGS: AMP-FSGS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06090227.
~20 spots leftby Nov 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top