Urinary Biomarkers of the Progression of Alport Kidney Disease
Completed
Conditions studied: Alport Syndrome
In brief
The purpose of the study is to determine if there are certain laboratory tests that can be performed to detect substances or features in a child's urine that can be used to measure the progress of Alport kidney disease and the effects of treatment. These tests and their results could be of use to measure responses to new treatments in future clinical trials.
Key facts
- Study ID
- NCT01705132
- Run by
- University of Minnesota
- People needed
- 80
- Starts
- 2012-06-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2013-07-30
Who can join
Age: 5 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects eligible for inclusion in this study have to fulfill all of the following criteria:
- Able to understand and comply with the requirements of the study and able to provide written informed consent.
- Male and female subjects ≥ 5 years of age.
- Physically able to provide a single first-morning urine sample of at least 30 mL (one ounce).
- Alport syndrome diagnosis: Clinical and/or histopathologic and/or genetic diagnosis of Alport Syndrome, as per the subject's physician and/or genotyping.
You may not qualify if…
- Subjects fulfilling any of the following criteria are not eligible for inclusion in this study:
- Use of investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- Chronic kidney disease, defined as a known diagnosis of CKD, and/or receiving chronic phosphate-lowering therapy or erythropoietin therapy.
- Ongoing chronic hemodialysis therapy and/or renal transplant recipient.
- Nephrotic-range proteinuria: spot urine protein-to-creatinine ratio ≥ 3 on at least 2 of the last 3 clinical assessments.
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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