- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02022189
Review of Kidney Biopsies of Dent Disease Patients
September 19, 2015 updated by: John Lieske, Mayo Clinic
Systematic Review of Clinical Biopsies of Dent Disease Patients
This study is being done to obtain pathology reports from all patients in the Dent disease registry who have had a kidney biopsy.
The investigator will collect the biopsy slides and reports in an attempt to determine if they have any common findings.
Study Overview
Detailed Description
If the patient agrees to be in the study, the patient will be asked to participate in the following:
- Sign a consent form indicating the patient's willingness to participate.
- Provide a signed medical release form allowing the investigator to request your official kidney biopsy reports, and also allowing the investigator to request the original slides for review. At the end of the study, all slides will be returned to the referring facility.
- The investigator will also review your medical record
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
All patients in the Dent Registry with a previous renal biopsy
Description
Inclusion Criteria:
- All patients in the Dent Disease Registry with a previous renal biopsy.
Exclusion Criteria:
- None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dent Disease patients
Patients with diagnosed Dent Disease
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biopsy changes
Time Frame: 2 years
|
The primary outcome will be to determine the number of glomeruli, percent globally sclerotic glomeruli, percent focally sclerotic glomeruli, and the severity of interstitial fibrosis (none, mild, moderate, severe) and interstitial crystals (none, mild, moderate, severe)
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (ACTUAL)
September 1, 2015
Study Completion (ACTUAL)
September 1, 2015
Study Registration Dates
First Submitted
December 6, 2013
First Submitted That Met QC Criteria
December 20, 2013
First Posted (ESTIMATE)
December 27, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 22, 2015
Last Update Submitted That Met QC Criteria
September 19, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-003738
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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