A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alport Syndrome Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Disease Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Hereditary Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Skin and Connective Tissue Diseases Urination Disorders Urogenital Abnormalities Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

Up to 18 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Number of Subjects Developing Microalbuminuria During Study Period

Time frame: 2007-2009

number of subjects developing microalbuminuria during study period

Secondary outcomes

Number of Subjects Developing Proteinuria During the Study Period

Time frame: 2007-2009

number of subjects developing proteinuria during the study period

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

University of Utah

Registry information

Acronym: MA

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Feb 25, 2008
Registry last updated: Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed