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Sponsored by: |
University of Minnesota |
Information provided by: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00481130 |
Over the past 30 years much has been learned about the molecular genetics and natural history of familial forms of hematuria. However, the enhanced understanding of these conditions has yet to generate effective therapies for Alport syndrome, the form of familial hematuria associated with end-stage renal disease. Males with Alport syndrome inevitably develop end-stage kidney failure, with a 50% likelihood of dialysis or kidney transplantation by age 25 years. There is no proven treatment for Alport syndrome, although studies in animals have suggested several promising potential therapies. Potential drug treatments that might delay or prevent the development of kidney failure exist, but need to be evaluated through clinical trails. Conducting clinical trails for proposed treatments for Alport syndrome present many challenges. Because Alport syndrome is not a common disease, informative clinical trials will require the collaboration of investigators at multiple centers.
The University of Minnesota, Department of Pediatrics, proposes to create the Alport Syndrome Treatments and Outcomes Registry (ASTOR) in order to facilitate clinical trials for the treatment of Alport Syndrome. This registry will be the first of its kind in North America. Because Alport syndrome is a rare disorder, recruitment of sufficient participants for meaningful therapeutic trials will require a multicenter effort. The primary objective of establishing and sustaining this registry is to enable clinical natural history studies and therapeutic trials to be conducted in children and adolescents with Alport syndrome.
Condition |
Alport Syndrome |
Genetics Home Reference related topics: | Alport syndrome nonsyndromic deafness |
Study Type: | Observational |
Study Design: | Family-Based, Other |
Official Title: | Alport Syndrome Treatments and Outcomes Registry |
Estimated Enrollment: | 500 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2012 |
Show Detailed Description |
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Family and individual history of a diagnosis of Alport syndrome, confirmed by skin biopsy, kidney biopsy, or molecular genetic analysis or diagnosis of Alport syndrome based on presence of hematuria and confirmed diagnosis of Alport syndrome in a first-degree relative.
Study Assessments
ASTOR central office staff will obtain informed consent form all participants along with medical and medication histories.
Inclusion criteria:
Exclusion Criteria:
Contact: Theresa F Cassidy, MPH | 612 626 7632 | cassi044@umn.edu |
United States, Minnesota | |||||
University of Minnesota | Recruiting | ||||
Minneapolis, Minnesota, United States, 55455 | |||||
Principal Investigator: Clifford Kashtan, MD |
University of Minnesota |
Principal Investigator: | Clifford Kashtan, MD | University of Minnesota, Department of Pediatrics |
Responsible Party: | University of Minnesota ( Clifford E. Kashtan ) |
Study ID Numbers: | 0704M05941 |
First Received: | May 30, 2007 |
Last Updated: | May 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00481130 |
Health Authority: | United States: Institutional Review Board |
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