HealthyNCT00365911
Prevalence of Renal Failure and Risk Factors in an Unreferred Healthy Population
A study testing Taking blood sample in people with Healthy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Blood sample is taken for measurement of serum creatinine, cystatin C, clone V haemoglobin, cholesterol, urine acid, glycemia and CRP. The medical file is gathered. There will be searched for an association between renal function and cardiovascular risk factors and risk factors by exposition to toxic substantia during… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Taking blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2006to Dec 2009
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20-55 years
- Male and female subjects
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Blood sample is taken for measurement of serum creatinine, cystatin C, clone V haemoglobin, cholesterol, urine acid, glycemia and CRP.
The medical file is gathered. There will be searched for an association between renal function and cardiovascular risk factors and risk factors by exposition to toxic substantia during work.
- Conditions
- Healthy
- Being tested
- Taking blood sample
- Keywords
- No specific condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking blood sampleProcedure or surgery
A blood sample will be taken.
What is being measured
The primary outcome is the main question the study is designed to answer.
A possible association between renal clearance and found cardiovascular risk factors and risk factors by exposition to toxic substantia during work.
Measured: At time T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Prevemed-Medibo, Medical Laboratory CRI
- Investigators
- Raymond Vanholder, MD, PhD, Principal investigator, University Hospital, GhentWim Van Biesen, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365911
- Sponsor's protocol ID
- 2006/038
- Status last verified
- Jun 2011
- First submitted
- 17 Aug 2006
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Tol A, Van Biesen W, Verbeke F, De Groote G, Vermeiren F, Eeckhaut K, Vanholder R. Towards a rational screening strategy for albuminuria: results from the unreferred renal insufficiency trial. PLoS One. 2010 Oct 13;5(10):e13328. doi: 10.1371/journal.pone.0013328.
PubMed 20967254
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Renal Failure and Risk Factors in an Unreferred Healthy Population
- ClinicalTrials.gov ID
- NCT00365911
- Acronym / sponsor ID
- 2006/038
- Conditions
- Healthy
- Keywords
- No specific condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Prevemed-Medibo, Medical Laboratory CRI
- Study start
- Mar 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Aug 2006 (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.
Blood sample is taken for measurement of serum creatinine, cystatin C, clone V haemoglobin, cholesterol, urine acid, glycemia and CRP.
The medical file is gathered. There will be searched for an association between renal function and cardiovascular risk factors and risk factors by exposition to toxic substantia during work.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20-55 years
- Male and female subjects
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Taking blood sampleA blood sample will be taken. | Procedure or surgery | – |
Primary outcome
A possible association between renal clearance and found cardiovascular risk factors and risk factors by exposition to toxic substantia during work.
Time frame: At time T0
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 2 Jun 2011.
- Derived from this study: PubMed 20967254van der Tol A, Van Biesen W, Verbeke F, De Groote G, Vermeiren F, Eeckhaut K, Vanholder R. Towards a rational screening strategy for albuminuria: results from the unreferred renal insufficiency trial. PLoS One. 2010 Oct 13;5(10):e13328. doi: 10.1371/journal.pone.0013328.
- Website University Hospital GhentLink 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.
Raymond Vanholder, MD, PhD principal investigator
University Hospital, Ghent
Wim Van Biesen, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taking blood sample in people with Healthy, run by University Hospital, Ghent at 1 site in Belgium.
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 0 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 2 Jun 2011. 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 Belgium. 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?
A possible association between renal clearance and found cardiovascular risk factors and risk factors by exposition to toxic substantia during work. (time frame: At time T0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00365911, which also lists 1 linked publication.
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 2 Jun 2011.