A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome - Full Text View

Sponsors and Collaborators:	University of Minnesota University of Utah
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00622544

Purpose

The goal of the Microalbuminuria in Untreated Boys with Alport Syndrome study is to gather information about critical clinical time points such as when patients with small amounts of protein (microalbuminuria) in their urine progress to larger amounts (overt proteinuria). Large amounts of protein in the urine is often an early sign of kidney disease.

Information needs to be collected in boys who are not taking medications known as angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in order to obtain accurate data about the length of time between the onset of microalbuminuria and the start of overt proteinuria. This new information will give physicians a better understanding of how to treat patients with Alport syndrome.

The information we gather by conducting this study will aid in planning future clinical trials because the identification of time points in disease progression, such as microalbuminuria and overt proteinuria, could reduce the time necessary to show a clinical benefit of a new treatment option.

The study has been approved by the University of Minnesota's Institutional Review Board.

Condition
Alport Syndrome

Genetics Home Reference related topics: Alport syndrome

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome

Further study details as provided by University of Minnesota:

Primary Outcome Measures:

microalbuminuria is a reliable marker of disease progression in Alport syndrome, and a potential endpoint for therapeutic trials. [ Time Frame: quarterly ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Each urine sample will be assayed for albumin, total protein and creatinine. The following definitions will be used:

Microalbuminuria: urine albumin:creatinine ratio (ACR) > 30 mcg/mg, on 3 consecutive measurements spaced one month apart
Overt proteinuria: urine protein:creatinine ratio (UPC) > 0.2 mg/mg, on 3 consecutive measurements spaced one month apart

Estimated Enrollment:	30
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Detailed Description:

Study Aims

To determine the average ages of onset of microalbuminuria and overt proteinuria in untreated boys with Alport syndrome
To determine the average duration of microalbuminuria before transition to overt proteinuria in untreated boys with Alport syndrome

This study does not involve treatment and is anticipated to last 3-5 years.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study population is comprised of approximately 30 males ranging in age from 0 - 18 at the time of enrollment.

Criteria

Inclusion Criteria:

Diagnosis of Alport syndrome, confirmed by skin biopsy, kidney biopsy, or molecular genetic analysis
Diagnosis of Alport syndrome, based on presence of hematuria and confirmed diagnosis of Alport syndrome in a first-degree relative
Male gender
Absence of overt proteinuria, defined as urine protein:creatinine ratio less than 0.2 mg/mg
Subject is not currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)

Exclusion Criteria:

Female gender
Presence of overt proteinuria
Current treatment with ACEI or ARB
End-stage kidney disease (on dialysis or kidney transplant recipient)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622544

Contacts

Contact: Theresa F Cassidy, MPH, CCRP

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

University of Utah

Investigators

Principal Investigator:

Clifford E Kashtan, MD

University of Minnesota

More Information

Click here for more information about the Prospective Study of Microalbuminuria in Untreated Boys with Alport Syndrome (Alport Syndrome Treatments and Outcomes Registry) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	University of Minnesota ( Clifford E. Kashtan, MD )
Study ID Numbers:	0707M11722
Study First Received:	February 13, 2008
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00622544
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

Microalbuminuria
Proteinuria

Study placed in the following topic categories:

Proteinuria
Urogenital Abnormalities
Alport syndrome
Collagen Diseases
Urologic Diseases

Nephritis
Connective Tissue Diseases
Kidney Diseases
Congenital Abnormalities
Nephritis, Hereditary

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009