Dent DiseaseNCT02022189
Review of Kidney Biopsies of Dent Disease Patients
An observational study of Dent Disease, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Dent Disease
- What is being tested?
- Renal Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients in the Dent Registry with a previous renal biopsy
Who may be able to join
- All patients in the Dent Disease Registry with a previous renal biopsy.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Dent Disease
- Being tested
- Renal Biopsy
- Keywords
- Dent, Dents, Dent Disease, Renal Biopsy, Kidney Biopsy, Clinical Biopsy
- Medical subject headings
- Dent Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal BiopsyProcedure or surgery
Also called All patients in the Dent Disease Registry with a previous renal biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Dent Disease patients | Patients with diagnosed Dent Disease Receives: Procedure: Renal Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dent DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Lieske, Mayo Clinic
- Investigators
- John C Lieske, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022189
- Sponsor's protocol ID
- 13-003738
- Status last verified
- Sep 2015
- First submitted
- 6 Dec 2013
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Review of Clinical Biopsies of Dent Disease Patients
- ClinicalTrials.gov ID
- NCT02022189
- Acronym / sponsor ID
- 13-003738
- Conditions
- Dent Disease
- Keywords
- Dent, Dents, Dent Disease, Renal Biopsy, Kidney Biopsy, Clinical Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dent Disease patients | – | Procedure: Renal BiopsyPatients with diagnosed Dent Disease |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients in the Dent Registry with a previous renal biopsy
Key inclusion criteria (1 listed)
- All patients in the Dent Disease Registry with a previous renal biopsy.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal BiopsyAlso: All patients in the Dent Disease Registry with a previous renal biopsy. | Procedure or surgery | Dent Disease patients |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
- Rare Kidney Stone ConsortiumLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C Lieske, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dent Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy changes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.