A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome

NCT ID: NCT00622544

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2012-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Alport Syndrome; Kidney Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility 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)

• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clifford E Kashtan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Related Links

https://astor.ahc.umn.edu/

Click here for more information about the Prospective Study of Microalbuminuria in Untreated Boys with Alport Syndrome (Alport Syndrome Treatments and Outcomes Registry)

Other Identifiers

0707M11722

Identifier Type: -

Identifier Source: org_study_id