Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT01705132
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2012-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urinary Biomarkers of the Progression of Alport Kidney Disease
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Urinary Biomarkers of the Progression of Alport Kidney Disease
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: