Trial record 3 of 7 for:    "Dent disease"

Review of Kidney Biopsies of Dent Disease Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
John Lieske, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02022189
First received: December 6, 2013
Last updated: June 30, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention
Dent Disease
Procedure: Renal Biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Systematic Review of Clinical Biopsies of Dent Disease Patients

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Biopsy changes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dent Disease patients
Patients with diagnosed Dent Disease
Procedure: Renal Biopsy
Other Name: All patients in the Dent Disease Registry with a previous renal biopsy.

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
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients in the Dent Registry with a previous renal biopsy

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022189

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Alicia M Meek    507-255-4347    meek.alicia@mayo.edu   
Contact: Mayo Clinic Rare Kidney Stone Consortium    800-270-4637    rarekidneystones@mayo.edu   
Principal Investigator: John C. Lieske, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: John C Lieske, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: John Lieske, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02022189     History of Changes
Other Study ID Numbers: 13-003738
Study First Received: December 6, 2013
Last Updated: June 30, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Dent
Dents
Dent Disease
Renal Biopsy
Kidney Biopsy
Clinical Biopsy

Additional relevant MeSH terms:
Dent Disease
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014