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NCT06090227 · ClinicalTrials.gov registry record · Phase 1
AMPK-activation by Metformin in FSGS: AMP-FSGS
A Phase 1 study of Focal Segmental Glomerulosclerosis, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT06090227: Recruiting Phase 1 study of Focal Segmental Glomerulosclerosis, sponsored by Yale University.
NCT06090227 is a Phase 1 study of Focal Segmental Glomerulosclerosis that is actively recruiting participants, run by Yale University. The registered enrollment target is 30 participants, below the 235-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06090227, a Phase 1 study of Focal Segmental Glomerulosclerosis, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Metformin + Standard of Care
- OTHER Placebo + Standard of Care
Study Locations (2)
Connecticut
- Yale New Haven Hospital - New Haven
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-12-14 |
| Est. Completion | 2027-11 |
| Phase | Phase 1 |
What NCT06090227 shows while recruiting
NCT06090227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 235-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 2 interventions - of which Metformin + Standard of Care is the first listed.
NCT06090227 reports a single indexed study location in Connecticut, New York.
Frequently Asked Questions
What is clinical trial NCT06090227 about?
NCT06090227 is a clinical study titled "AMPK-activation by Metformin in FSGS: AMP-FSGS". 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).
What is the current status of trial NCT06090227?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-12-14. Estimated completion is 2027-11.
What conditions does trial NCT06090227 study?
This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis.
What interventions are being tested in trial NCT06090227?
The interventions under investigation include: Metformin + Standard of Care (DRUG), Placebo + Standard of Care (OTHER).
Who is sponsoring clinical trial NCT06090227?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06090227 being conducted?
This trial has 2 study locations across Connecticut, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Focal Segmental Glomerulosclerosis
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Where NCT06090227's enrollment target sits among peer trials
30 14th of 19 higher than 4 of 19 other Focal Segmental Glomerulosclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Focal Segmental Glomerulosclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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