NCT02022189

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

December 6, 2013

Last Update Submit

September 19, 2015

Conditions

Dent Disease

Keywords

DentDentsDent DiseaseRenal BiopsyKidney BiopsyClinical Biopsy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Dent Disease patients

Patients with diagnosed Dent Disease

Procedure: Renal Biopsy

Interventions

Renal BiopsyPROCEDURE
Also known as: All patients in the Dent Disease Registry with a previous renal biopsy.
Dent Disease patients

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in the Dent Registry with a previous renal biopsy

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Dent Disease

Condition Hierarchy (Ancestors)

Renal Tubular Transport, Inborn ErrorsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • John C Lieske, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 27, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

US(1)