KidneyNCT01235104
Impact of Total Nephrectomy on Patients With Kidney Stone
An observational study of Kidney and Urolithiasis, run by University of Sao Paulo General Hospital.
Trial summary
The aim of this study is to investigate the outcomes of total nephrectomy on patients with kidney stone disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney, Urolithiasis, Nephrectomy
- What is being tested?
- Total nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Oct 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with kidney stone submitted to total nephrectomy from january 2001 to october 2010 at University of Sao Paulo General Hospital
Who may be able to join
- Total nephrectomy
- Kidney stone disease
Who cannot join
- < 18 y.o.
- Cancer
- Kidney transplant
- Solitary kidney
About this study
The aim of this study is to investigate the outcomes of total nephrectomy on patients with kidney stone disease.
Read the detailed description
The aim of this study is to retrospectively investigate the effects of total nephrectomy on renal function, quality of life, early and late complications and development of the stone disease on the remnant unit on patients with kidney stone disease.
- Conditions
- Kidney, Urolithiasis, Nephrectomy, Treatment Outcome, Complications
- Being tested
- Total nephrectomy
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total nephrectomyProcedure or surgery
Total nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Total nephrectomy | Not described Receives: Procedure: Total nephrectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startJan 2001
- Primary completionOct 2010
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KidneyStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Alexandre Danilovic, M.D., Ph. D., Principal investigator, Department of Urology of University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235104
- Sponsor's protocol ID
- 0652/10
- Status last verified
- Jan 2001
- First submitted
- 3 Nov 2010
- Last updated
- 5 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Total Nephrectomy on Patients With Kidney Stone
- ClinicalTrials.gov ID
- NCT01235104
- Acronym / sponsor ID
- 0652/10
- Conditions
- Kidney, Urolithiasis, Nephrectomy, Treatment Outcome, Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (estimated)
- First posted
- 5 Nov 2010 (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.
The aim of this study is to investigate the outcomes of total nephrectomy on patients with kidney stone disease.
Detailed description
The aim of this study is to retrospectively investigate the effects of total nephrectomy on renal function, quality of life, early and late complications and development of the stone disease on the remnant unit on patients with kidney stone disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total nephrectomy | – | Procedure: Total nephrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with kidney stone submitted to total nephrectomy from january 2001 to october 2010 at University of Sao Paulo General Hospital
Key inclusion criteria (2 listed)
- Total nephrectomy
- Kidney stone disease
Key exclusion criteria (4 listed)
- < 18 y.o.
- Cancer
- Kidney transplant
- Solitary kidney
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 |
|---|---|---|
| Total nephrectomyTotal nephrectomy | Procedure or surgery | Total nephrectomy |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2010.
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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.
Alexandre Danilovic, M.D., Ph. D. principal investigator
Department of Urology of University of Sao Paulo General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney and Urolithiasis, run by University of Sao Paulo General Hospital.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 5 Nov 2010.