AMPK-activation by Metformin in FSGS: AMP-FSGS

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06090227
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Dec 14, 2023
Status verified
Jan 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin + Standard of Care
    Administration of daily oral extended-release Metformin 500 mg tablets with standard of care for 6 months.
  • Placebo Comparator: Placebo + Standard of Care
    Administration of daily placebo tablets with standard of care for 6 months.

Primary Outcome Measure

Slope of urinary NPHS2:Creatinine ratio [ Time Frame: 6 months following randomization ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510
Madhav Menon
[email protected]
Francis P Wilson, MD (SUB_INVESTIGATOR)
Randy Luciano, MD PhD (SUB_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
Joji Tokita (SUB_INVESTIGATOR)
Kristin Meliambro (SUB_INVESTIGATOR)
Jia Fu (SUB_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Yale New Haven Hospital· New Haven, CTMount Sinai Hospital· New York, NY

Related Studies