A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of Subjects Developing Microalbuminuria During Study Period
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Female gender
- •Presence of overt proteinuria
- •Current treatment with ACEI or ARB
- •End-stage kidney disease (on dialysis or kidney transplant recipient)
结局指标
主要结局
Number of Subjects Developing Microalbuminuria During Study Period
时间窗: 2007-2009
number of subjects developing microalbuminuria during study period
次要结局
- Number of Subjects Developing Proteinuria During the Study Period(2007-2009)