Antiproteinuric Agents and Fabry Disease
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Purpose
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 |
|---|
|
Fabry Disease Proteinuria |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | Observational Study of Antiproteinuric Agents in Patients With Fabry Disease Treated With Enzyme Replacement Therapy |
| Estimated Enrollment: | 12 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | December 2006 |
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.
Eligibility| Ages Eligible for Study: | 14 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- genetically confirmed Fabry disease
- institution of commercially available agalsidase-beta
Exclusion Criteria:
- s/p kidney transplant
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-0006 | |
| Principal Investigator: | David G Warnock, MD | University of Alabama at Birmingham |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00343577 History of Changes |
| Other Study ID Numbers: | X050202007 |
| Study First Received: | June 21, 2006 |
| Last Updated: | June 21, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
proteinuria ARBs agalsidase-beta MDRD estimated GFR Chronic kidney disease |
Additional relevant MeSH terms:
|
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 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 Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013