Review of Kidney Biopsies of Dent Disease Patients

Dent Disease Clinical Trial

Official title:

Systematic Review of Clinical Biopsies of Dent Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022189
• Other study ID #: 13-003738
• Status: Completed
• Phase: N/A
• First received: December 6, 2013
• Last updated: September 19, 2015
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients in the Dent Disease Registry with a previous renal biopsy.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dent Disease

Intervention

Procedure:
• Renal Biopsy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biopsy changes	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	No

External Links

•   Rare Kidney Stone Consortium