Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Alabama at Birmingham |
---|---|
Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00446862 |
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
Condition | Intervention |
---|---|
Fabry Disease Proteinuria |
Drug: enalapril and other angiotensin converting enzyme inhibitors; losartan and other angiotensin receptor blockers |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Multi-Center, Open-Label Study of the Safety and Efficacy of Control of Proteinuria With ACE Inhibitors and ARBS in Patients With Fabry Disease Who Are Receiving Fabrazyme®: The FAACET Study |
Estimated Enrollment: | 40 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2010 |
Ages Eligible for Study: | 19 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Adult patients with confirmed diagnosis of Fabry disease, who are receiving enzyme replacement therapy with agalsidase beta
Inclusion Criteria:
Patients with either:
Exclusion Criteria:
Contact: David G Warnock, MD | 205 934 3585 | dwarnock@uab.edu |
Contact: Leslie L Jackson, RN | (205) 996-2227 | lesliea@uab.edu |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294-0006 | |
Contact: Leslie Jackson, RN 205-934-3585 lesliea@uab.edu | |
Principal Investigator: Ruth C Campbell, MD | |
United States, Georgia | |
Emory University | Not yet recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Dawn Laney, MS 404-778-8518 dlaney@genetics.emory.edu | |
Principal Investigator: Anthony Guasch, MD | |
United States, Illinois | |
Feinberg School of Medicine, Northwestern University | Recruiting |
Chicago, Illinois, United States, 60614 | |
Contact: Shanna Randolph, APN 773-880-4462 srandolph@childrensmemorial.org | |
Principal Investigator: Joel Charrow, MD | |
United States, Iowa | |
University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Kathleen Lilli, RN 319-356-0575 kathleen-lilli@uiowa.edu | |
Principal Investigator: Christie Thomas, MD | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Virginia Clark, RN 718-826-8281 vclarke1@partners.org | |
Principal Investigator: Katherina Sims, MD | |
Germany | |
University of Wurzburg Medizinische Klink und Poliklinik I | Recruiting |
Wurzburg, Germany, 97080 | |
Contact: Andrea Emmert, RN +49-931/31-2199 emmert_a@klinik.uni-wuerzburg.de | |
Principal Investigator: Frank Breunig, MD | |
Slovenia, Gradec | |
General Hospital Slovenj Gradec | Recruiting |
Ljubljana, Gradec, Slovenia, 1 | |
Contact: Bojan Vujkovac, MD +386 41 430 509 bojan.vujkovac@guest.arnes.si | |
Contact: Vesna Korat +386 2 88 23 400 fabry@sb-sg.si | |
Principal Investigator: Bojan Vujkovac, MD |
Principal Investigator: | David G Warnock, MD | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham ( Jane Fant, PhD Assistant VP Sponsored Programs Administration ) |
Study ID Numbers: | X070104001, UAB NEPHROLOGY 001-2006 |
Study First Received: | March 11, 2007 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00446862 |
Health Authority: | United States: Institutional Review Board |
Definition: Fabry disease Definition: Progression Definition: MDRD GFR Definition: Chronic Kidney Disease |
Definition: Proteinuria Definition: Enzyme Replacement Therapy Definition: Anti-proteinuric therapy |
Lipid Metabolism, Inborn Errors Sphingolipidoses Disease Progression Kidney Failure, Chronic Brain Diseases Metabolism, Inborn Errors Signs and Symptoms Enalapril Ceramide trihexosidosis Urologic Diseases Fabry Disease Genetic Diseases, X-Linked Brain Diseases, Metabolic, Inborn Kidney Diseases Losartan |
Metabolic Diseases Urination Disorders Lysosomal Storage Diseases Fabry disease Central Nervous System Diseases Sphingolipidosis Proteinuria Enalaprilat Genetic Diseases, Inborn Renal Insufficiency, Chronic Lipidoses Metabolic disorder Brain Diseases, Metabolic Lipid Metabolism Disorders |
Urological Manifestations Lysosomal Storage Diseases, Nervous System Nervous System Diseases |