Clinical Trial: A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome
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 Summary:
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.
Sponsor: University of Minnesota - Clinical and Translational Science Institute
Current Primary Outcome: microalbuminuria is a reliable marker of disease progression in Alport syndrome, and a potential endpoint for therapeutic trials. [ Time Frame: quarterly ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Minnesota - Clinical and Translational Science Institute
Dates:
Date Received: February 13, 2008
Date Started: July 2007
Date Completion:
Last Updated: December 12, 2013
Last Verified: December 2013
