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NCT00814255 · ClinicalTrials.gov registry record · Phase 2

Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial

A Phase 2 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 2
Development phase
32
Enrollment target

NCT00814255: Completed Phase 2 study, sponsored by NYU Langone Health.

NCT00814255 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00814255, a Phase 2 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 2
Development phase
32 participants
Enrollment target

Study Summary

This project will test whether adalimumab,and/or galactose can safely reduce proteinuria (abnormal amounts of protein in the urine) and protect kidney function better than standard treatment for patients with focal segmental glomerulosclerosis (FSGS).

Primary Outcome

Number of participants with a reduction in proteinuria at 6 months by \> 50% of the value at screening AND stable GFR defined as greater than 75 ml/min/1.73m2 in those with an initial value above 90 OR within 25% of baseline for remaining patients.

Interventions

  • DRUG Adalimumab
  • DRUG Lisinopril, losartan, and atorvastatin
  • DRUG galactose

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2008-12
Est. Completion 2014-02
Phase Phase 2
NYU Langone Health

1,164 total trials

What the finished NCT00814255 record still lists

NCT00814255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).

The record links to 0 conditions, and to 3 interventions - of which Adalimumab is the first listed.

NCT00814255 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00814255 about?

NCT00814255 is a clinical study titled "Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial". This project will test whether adalimumab,and/or galactose can safely reduce proteinuria (abnormal amounts of protein in the urine) and protect kidney function better than standard treatment for patients with focal segmental glomerulosclerosis (FSGS).

What is the current status of trial NCT00814255?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2008-12. Estimated completion is 2014-02.

What interventions are being tested in trial NCT00814255?

The interventions under investigation include: Adalimumab (DRUG), Lisinopril, losartan, and atorvastatin (DRUG), galactose (DRUG).

Who is sponsoring clinical trial NCT00814255?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00814255's enrollment target sits among peer trials

32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00814255, the US trial registry maintained by the National Library of Medicine. NCT00814255 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.