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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00343577
Other study ID # X050202007
Secondary ID
Status Completed
Phase N/A
First received June 21, 2006
Last updated November 17, 2013
Start date January 2001
Est. completion date December 2006

Study information

Verified date June 2006
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 95 Years
Eligibility Inclusion Criteria:

- genetically confirmed Fabry disease

- institution of commercially available agalsidase-beta

Exclusion Criteria:

- s/p kidney transplant

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tahir H, Jackson LL, Warnock DG. Antiproteinuric therapy and fabry nephropathy: sustained reduction of proteinuria in patients receiving enzyme replacement therapy with agalsidase-beta. J Am Soc Nephrol. 2007 Sep;18(9):2609-17. Epub 2007 Jul 26. — View Citation

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