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Antiproteinuric Agents and Fabry Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00343577
Recruitment Status : Completed
First Posted : June 23, 2006
Last Update Posted : November 19, 2013
Sponsor:
Information provided by:
University of Alabama at Birmingham

Study Description
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Brief Summary:
Fabry disease is a rare disorder that often has kidney involvement with increased urine protein excretion. Proteinuria is recognized as an important risk factor for progression of chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry disease who already are receiving enzyme replacement therapy. A longitudinal, observational study is being undertaken to determine the utility of these agents in Fabry disease, realizing that these agents are primarily indicated for reducing systemic blood pressure, and most patients with Fabry disease have relatively low blood pressures at baseline.

Condition or disease
Fabry Disease Proteinuria

Detailed Description:
Fabry disease is a rare disorder that often has kidney involvement with increased urine protein excretion. Proteinuria is recognized as an important risk factor for progression of chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry disease who already are receiving enzyme replacement therapy. A longitudinal, observational study is being undertaken to determine the utility of these agents in Fabry disease, realizing that these agents are primarily indicated for reducing systemic blood pressure, and most patients with Fabry disease have relatively low blood pressures at baseline.
Study Design
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Study Type : Observational
Enrollment : 12 participants
Time Perspective: Prospective
Official Title: Observational Study of Antiproteinuric Agents in Patients With Fabry Disease Treated With Enzyme Replacement Therapy
Study Start Date : January 2001
Study Completion Date : December 2006

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   14 Years to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • genetically confirmed Fabry disease
  • institution of commercially available agalsidase-beta

Exclusion Criteria:

  • s/p kidney transplant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343577


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: David G Warnock, MD University of Alabama at Birmingham
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00343577    
Other Study ID Numbers: X050202007
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: June 2006
Keywords provided by University of Alabama at Birmingham:
proteinuria
ARBs
agalsidase-beta
MDRD estimated GFR
Chronic kidney disease
Additional relevant MeSH terms:
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Fabry Disease
Proteinuria
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, X-Linked
 Genetic Diseases, Inborn
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Urological Manifestations