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The Fabrazyme® and Arbs and ACE Inhibitor Treatment (FAACET) Study
NCT00446862 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00446862 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Alabama, Georgia, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00446862?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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