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

This study has been completed.
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00622544
First received: February 13, 2008
Last updated: December 12, 2013
Last verified: December 2013
  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

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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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

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

Enrollment: 44
Study Start Date: July 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
University of Utah
Investigators
Principal Investigator: Clifford E Kashtan, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00622544     History of Changes
Other Study ID Numbers: 0707M11722
Study First Received: February 13, 2008
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Microalbuminuria
Proteinuria

Additional relevant MeSH terms:
Albuminuria
Nephritis, Hereditary
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urogenital Abnormalities
Nephritis
Kidney Diseases
Congenital Abnormalities
Collagen Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 23, 2014