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Clinical trialNCT00446862CompletedObservational

The Fabrazyme® and Arbs and ACE Inhibitor Treatment (FAACET) Study

SponsorUniversity of Alabama at BirminghamEnrollment36Fabry DiseaseProteinuria
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Slovenia
  • General Hospital Slovenj Gradec

    Ljubljana, Gradec, Slovenia

United States
  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • Emory University

    Atlanta, Georgia, United States

  • Feinberg School of Medicine, Northwestern University

    Chicago, Illinois, United States

  • University of Iowa

    Iowa City, Iowa, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Enalapril and other angiotensin converting enzyme inhibitors; losartan and other angiotensin receptor blockers
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Mar 2007
Primary completion
30 Jun 2012
Completion
31 Dec 2012
Last update posted
19 Nov 2013
Registered enrollment
36
Registry id
NCT00446862

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.