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NCT01696253 · ClinicalTrials.gov registry record
Multi-center Controlled Clinical Trials in Alport Syndrome-A Feasibility Study
A clinical trial, sponsored by University of Minnesota.
- Completed
- Registry status
- 360
- Enrollment target
NCT01696253: Completed study, sponsored by University of Minnesota.
NCT01696253 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 360 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01696253 has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- 360 participants
- Enrollment target
Study Summary
Over the past 30 years much has been learned about the molecular genetics and natural history of familial forms of hematuria. However, enhanced understanding of these conditions has yet to generate effective therapies for Alport syndrome(AS), the form of familial hematuria associated with end-stage renal disease. Males with AS inevitably develop end-stage kidney failure, with a 50% likelihood of dialysis or kidney transplantation by age 25 years. There is no proven treatment for AS, although studies in animals have suggested several promising potential therapies. Pharmacological or biological treatments that might delay or prevent the development of kidney failure exist, but need to be evaluated through clinical trials. Researchers interested in implementing clinical trials in AS will face several challenges, the foremost of which is the relative rarity of the disease, necessitating aggressive efforts to identify and recruit potential subjects for multi-center collaborative clinical trials. The Alport Syndrome Research Collaborative (ARC) was established in 2009 as a partnership of the Alport Syndrome Treatments and Outcomes Registry (ASTOR), the European Alport Registry and centers of AS research in Canada, China and France with the objective of testing potential treatments to delay or prevent terminal renal failure in people with AS. In this feasibility study the five ARC centers will interrogate existing AS registries and databases, and monitor accrual of new AS cases over an 18-month period, in order to quantify subjects in the disease categories of interest. As part of this project we will examine the utility of urinary uromodulin excretion as a marker of kidney injury and potential trial endpoint in AS clinical trials. Our goals are to (1) demonstrate that participating centers have access to sufficient numbers of males and females with AS to populate adequately-powered clinical trials focused on two clinical targets, microalbuminuria and overt proteinuria, an
Primary Outcome
The primary outcome to be measured is the number of subjects with Alport syndrome who would meet eligibility criteria for an anticipated clinical treatment trial. Power calculations indicate that the trial would require recruitment of 90 total subjects, stratified into 4 groups based on urine albumin and protein excretion.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2012-09 |
| Est. Completion | 2017-12 |
What the finished NCT01696253 record still lists
NCT01696253 is an observational study that tracks outcomes without assigning an intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01696253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01696253 about?
NCT01696253 is a clinical study titled "Multi-center Controlled Clinical Trials in Alport Syndrome-A Feasibility Study". Over the past 30 years much has been learned about the molecular genetics and natural history of familial forms of hematuria. However, enhanced understanding of these conditions has yet to generate effective therapies for Alport syndrome(AS), the form of familial hematuria associated with end-stage ...
What is the current status of trial NCT01696253?
This trial is currently completed. The enrollment target is 360 participants. The study started on 2012-09. Estimated completion is 2017-12.
Who is sponsoring clinical trial NCT01696253?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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