A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 7/22/2018 |
| Start Date: | July 2007 |
| End Date: | July 2012 |
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.
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 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.
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.
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)
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