Trial record 1 of 9 for:    "alport syndrome"
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Alport Syndrome Treatments and Outcomes Registry (ASTOR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00481130
First received: May 30, 2007
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Family-Based
Target Follow-Up Duration: 10 Years
Official Title: Alport Syndrome Treatments and Outcomes Registry

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Data Collection: natural history study [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: September 2007
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion criteria:

  • Age < 30
  • 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
  • Normal renal function, as measured by serum creatinine or estimated or measured creatinine clearance

Exclusion Criteria:

  • Uncertain diagnosis of Alport syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481130

Contacts
Contact: Theresa F Cassidy, MPH 612 626 7632 cassi044@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Clifford Kashtan, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Clifford Kashtan, MD University of Minnesota, Department of Pediatrics
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00481130     History of Changes
Other Study ID Numbers: 0704M05941
Study First Received: May 30, 2007
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Alport Syndrome
x linked
autosomal dominant Alport syndrome
glomerular basement membrane
hereditary nephritis
familial benign haematuria
type IV collagen
hereditary nephritis with neurosensory deafness
vison loss

Additional relevant MeSH terms:
Nephritis, Hereditary
Urogenital Abnormalities
Nephritis
Kidney Diseases
Urologic Diseases
Congenital Abnormalities
Collagen Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 22, 2014