Alport Syndrome, Kidney Disease
Conditions
Keywords
Microalbuminuria, Proteinuria
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 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.
Interventions
None listed
Sponsors
University of Utah
University of Minnesota
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
No minimum to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Developing Microalbuminuria During Study Period | 2007-2009 | number of subjects developing microalbuminuria during study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Developing Proteinuria During the Study Period | 2007-2009 | number of subjects developing proteinuria during the study period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observational Study: no Arms - One Group Observational study of urine albumin and protein excretion in untreated boys with Alport syndrome | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Observational Study: no Arms - One Group |
|---|---|
| Age, Categorical <=18 years | 35 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9.9 years STANDARD_DEVIATION 3.1 |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Subjects Developing Microalbuminuria During Study Period
number of subjects developing microalbuminuria during study period
Time frame: 2007-2009
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational Study: no Arms - One Group | Number of Subjects Developing Microalbuminuria During Study Period | 35 Participants |
Secondary
Number of Subjects Developing Proteinuria During the Study Period
number of subjects developing proteinuria during the study period
Time frame: 2007-2009
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational Study: no Arms - One Group | Number of Subjects Developing Proteinuria During the Study Period | 35 Participants |