A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome (MA)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome|
- 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
|Study Start Date:||July 2007|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622544
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Clifford E Kashtan, MD||University of Minnesota - Clinical and Translational Science Institute|