Diseases
Antiproteinuric Agents and Fabry
| Descriptive Information Fields | |||||
|---|---|---|---|---|---|
| Brief Title † | Antiproteinuric Agents and Fabry Disease | ||||
| Official Title † | Observational Study of Antiproteinuric Agents in Patients With Fabry Disease Treated With Enzyme Replacement Therapy | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Natural History, Longitudinal, Defined Population, Prospective Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Fabry Disease Proteinuria |
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| Intervention † | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 12 | ||||
| Start Date † | January 2001 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 14 Years to 95 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00343577 | ||||
| Organization ID | X050202007 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of Alabama at Birmingham | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | University of Alabama at Birmingham | ||||
| Verification Date | June 2006 | ||||
| First Received Date † | June 21, 2006 | ||||
| Last Updated Date | June 21, 2006 | ||||
†† WHO trial registration data element that is required only if it exists.
