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NCT00446862 · ClinicalTrials.gov registry record
The Fabrazyme® and Arbs and ACE Inhibitor Treatment (FAACET) Study
A clinical trial of Fabry Disease and Proteinuria, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- 36
- Enrollment target
- 6
- Study locations
NCT00446862 is a study of Fabry Disease and Proteinuria that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 36 participants, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (93% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT00446862, a study of Fabry Disease and Proteinuria, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- 36 participants
- Enrollment target
- 6
- Study locations
Study Summary
The primary hypothesis is that titration of ACE inhibitor and Angiotensin Receptor Blockers (ARBs)to reduce urine protein excretion to \< 500 mg per day in Fabry Patients receiving agalsidase beta therapy at 1 mg/kg every two weeks will slow the progression rate of decline of glomerular filtration rate (GFR) compared to case controls drawn from the Genzyme-sponsored Phase III extension study (GFR 60 to 125 ml/min/1.73 m², urine protein \> 1 gram/day) or the Phase IV study (GFR 20 to 60 ml/min/1.73 m², urine protein \> 0.5 gram/day). After a 3 month initial Evaluation Phase, the patients will be followed during a 24 month Observation Phase. FAACET is an open label, prospective observational study. The primary objective is reduction of first morning urine protein/creatinine ratio to \< 0.5 gram/gram. The primary outcome measure is the regression slope of MDRD GFR with time in years
Conditions Studied
Interventions
- DRUG enalapril and other angiotensin converting enzyme inhibitors; losartan and other angiotensin receptor blockers
Study Locations (6)
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Emory University - Atlanta
Illinois
- Feinberg School of Medicine, Northwestern University - Chicago
Iowa
- University of Iowa - Iowa City
Massachusetts
- Massachusetts General Hospital - Boston
Gradec
- General Hospital Slovenj Gradec - Ljubljana
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2007-03 |
| Est. Completion | 2012-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00446862
The ClinicalTrials.gov registry entry for NCT00446862 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (93% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Fabry Disease appearing as the primary indexed condition, and to 1 intervention - of which enalapril and other angiotensin converting enzyme inhibitors; losartan and other angiotensin receptor blockers is the first listed.
NCT00446862 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Alabama, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT00446862 about?
NCT00446862 is a clinical study titled "The Fabrazyme® and Arbs and ACE Inhibitor Treatment (FAACET) Study". The primary hypothesis is that titration of ACE inhibitor and Angiotensin Receptor Blockers (ARBs)to reduce urine protein excretion to \< 500 mg per day in Fabry Patients receiving agalsidase beta therapy at 1 mg/kg every two weeks will slow the progression rate of decline of glomerular filtration r...
What is the current status of trial NCT00446862?
This trial is currently completed. The enrollment target is 36 participants. The study started on 2007-03. Estimated completion is 2012-12.
What conditions does trial NCT00446862 study?
This clinical trial studies the following conditions: Fabry Disease, Proteinuria.
What interventions are being tested in trial NCT00446862?
The interventions under investigation include: enalapril and other angiotensin converting enzyme inhibitors; losartan and other angiotensin receptor blockers (DRUG).
Who is sponsoring clinical trial NCT00446862?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00446862 being conducted?
This trial has 6 study locations across Alabama, Georgia, Illinois, Iowa, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.