Expired Study
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Minneapolis, Minnesota 55455


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.


Study summary:

Study Aims 1. To determine the average ages of onset of microalbuminuria and overt proteinuria in untreated boys with Alport syndrome 2. 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.


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)


Study is Available At:


Original ID:

0707M11722


NCT ID:

NCT00622544


Secondary ID:


Study Acronym:

MA


Brief Title:

A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome


Official Title:

A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome


Overall Status:

Completed


Study Phase:

N/A


Genders:

Male


Minimum Age:

N/A


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Minnesota - Clinical and Translational Science Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

44


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clifford E Kashtan, MD
Principal Investigator
University of Minnesota - Clinical and Translational Science Institute

Study Dates

Start Date:July 2007
Completion Date:July 2012
Completion Type:Actual
Primary Completion Date:July 2012
Primary Completion Type:Actual
Verification Date:September 2017
Last Changed Date:September 22, 2017
First Received Date:February 13, 2008
First Results Date:May 2, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Subjects Developing Microalbuminuria During Study Period
Time Frame:2007-2009
Safety Issues:False
Description:number of subjects developing microalbuminuria during study period
Outcome Type:Secondary Outcome
Measure:Number of Subjects Developing Proteinuria During the Study Period
Time Frame:2007-2009
Safety Issues:False
Description:number of subjects developing proteinuria during the study period

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Minnesota - Clinical and Translational Science Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Utah

Samples and Retentions

Sample Retention:Samples Without DNA
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
Study Population: The study population is comprised of approximately 30 males ranging in age from 0 - 18 at the time of enrollment.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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