Urinary Biomarkers of the Progression of Alport Kidney Disease
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.
|Study Design:||Observational Model: Family-Based
Time Perspective: Prospective
|Official Title:||Urinary Biomarkers of the Progression of Alport Kidney Disease|
- Urine levels of biomarkers, corrected for urine creatinine, in Alport subjects stratified by magnitude of proteinura. [ Time Frame: This is a cross-sectional study. Subjects will submit a single urine sample (Day 1). ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Subjects submit first morning urine. Portion of urine retained for ASTOR repository.
|Study Start Date:||June 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
This is a prospective cross-sectional, observational, single-center study of affected Alport patients who have not progressed to advanced chronic renal insufficiency (CKD Stages 4 or 5), and who do not have nephrotic range proteinuria (urine protein-to-creatinine ratio > 3). There will be no required study site visits. Instead, encounters will occur via telephone with subjects when they are at home. This study consists of a single, first morning voided urine collection for subjects who meet eligibility criteria. Eligibility criteria and informed consent can be obtained via telephone in order to be as non-intrusive to the subject as possible.
Alport subjects will be recruited via the Alport Syndrome Treatments and Outcome Registry (ASTOR, University of Minnesota). ASTOR is the largest Alport Syndrome registry in the USA, comprised of approximately 500 people affected by Alport Syndrome. Subjects who meet eligibility criteria will be asked to provide clinical and demographic information and a single urine sample. A portion of the de-identified sample will be sent to Covance Laboratories for processing for Novartis and the remainder will be processed, stored and analyzed at the University of Minnesota. Subjects who provide consent will be given a kit and instructions for collecting the urine sample. Kits will then be returned via overnight courier to the study site. ASTOR study personnel will then communicate with subjects via the telephone to confirm proper first-morning void collection technique, and to obtain clinical historical information.
Approximately 80 Alport subjects will be enrolled in this study via ASTOR. Of the 80 Alport subjects, approximately 25% (N = 20) should have no significant proteinuria (spot urine protein-to-creatinine ratio ≤ 0.2), and approximately 75% (N = 60) should have non-postural, non-nephrotic proteinuria (defined as spot urine protein-to-creatinine ratio > 0.2 and < 3 on at least 2 of the last 3 clinical assessments). Approximately 40 healthy volunteers will provide urine samples elsewhere, outside the scope of this protocol. Healthy volunteer urine samples need not be first-morning voided specimens, however each specimen will be screened via dipstick for semi-quantitative protein analysis. Only samples with negative or trace protein on dipstick will be included in the study.
Informed consent forms will be included in the kit sent to each eligible Alport subject. Informed consent will take place via telephone, and preferably via video chat/Skype whenever possible.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01705132
|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|