- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01705132
Urinary Biomarkers of the Progression of Alport Kidney Disease
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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).
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This is a cross-sectional study. Subjects will submit a single urine sample (Day 1).
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 205M13905
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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