NCT06090227

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
18mo left

Started Dec 2023

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Dec 2023Nov 2027

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 14, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

3.9 years

First QC Date

October 13, 2023

Last Update Submit

January 30, 2026

Conditions

Focal Segmental Glomerulosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months following randomization

Secondary Outcomes (28)

  • estimated Glomerular Filtration Rate (eGFR)

    6 months post-randomization

  • Slope of eGFR

    6 months post-randomization

  • Urine protein:creatinine ratio

    6 months post-randomization

  • Slope of urine protein:creatinine ratio

    6 months post-randomization

  • Complete remission

    6 months post-randomization

  • +23 more secondary outcomes

Other Outcomes (2)

  • Body Mass Index (BMI)

    3 months post-randomization

  • Body Mass Index (BMI)

    6 months post-randomization

Study Arms (2)

Metformin + Standard of Care

EXPERIMENTAL

Administration of daily oral extended-release Metformin 500 mg tablets with standard of care for 6 months.

Drug: Metformin + Standard of Care

Placebo + Standard of Care

PLACEBO COMPARATOR

Administration of daily placebo tablets with standard of care for 6 months.

Other: Placebo + Standard of Care

Interventions

Metformin + Standard of CareDRUG

Administration of daily oral extended-release Metformin 500 mg tablets with standard of care for 6 months.

Metformin + Standard of Care
Placebo + Standard of CareOTHER

Administration of daily placebo tablets with standard of care for 6 months.

Placebo + Standard of Care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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.
  • 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 end of VPA administration. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

You may not qualify if:

  • 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 \< 100,000/µL; INR \> 1.5; Bleeding diathesis or blood thinner use contraindicating biopsy.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental

Interventions

MetforminStandard of Care

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Madhav Menon, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Cijiang He

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madhav C Menon, MD

CONTACT

20373734507madhav.menon@yale.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

December 14, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)