A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome (MA)

• ClinicalTrials.gov Identifier: NCT00622544
• Recruitment Status: Completed
• First Posted: February 25, 2008
• Results First Posted: July 20, 2018
• Last Update Posted: July 20, 2018
• Sponsor: University of Minnesota
• Collaborator: University of Utah
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease
Alport Syndrome; Kidney Disease

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 44 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome
• Study Start Date: July 2007
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: July 2012

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects Developing Microalbuminuria During Study Period [ Time Frame: 2007-2009 ]
   number of subjects developing microalbuminuria during study period

Secondary Outcome Measures :

1. Number of Subjects Developing Proteinuria During the Study Period [ Time Frame: 2007-2009 ]
   number of subjects developing proteinuria during the study period

Biospecimen Retention:   Samples Without DNA

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

Eligibility Criteria

• Ages Eligible for Study: up to 18 Years (Child, Adult)
• Sexes 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

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

University of Utah

Investigators

• Principal Investigator: Clifford E Kashtan, MD; University of Minnesota

More Information

Additional Information:

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

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT00622544
• Other Study ID Numbers: 0707M11722
• First Posted: February 25, 2008
• Results First Posted: July 20, 2018
• Last Update Posted: July 20, 2018
• Last Verified: September 2017

Keywords provided by University of Minnesota:

Microalbuminuria; Proteinuria

Additional relevant MeSH terms:

Kidney Diseases; Nephritis, Hereditary; Syndrome; Disease; Pathologic Processes; Urologic Diseases; Urogenital Abnormalities; Nephritis; Congenital Abnormalities; Collagen Diseases; Connective Tissue Diseases