Chronic Renal FailurePre-HDNCT00608998
Identification of Cardiovascular Risk Factors Linked to Renal Failure Progression
An observational study of Chronic Renal Failure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this study is to appreciate the influence of renal failure progression on vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Renal Failure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2007to Oct 2011
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Patient who has signed the written consent form
- Patient aged > 18 and < 90 years
- Chronic renal failure defined by glomerular filtration rate (GFR)
- group 1: GFR >90 mL/min with urinary biological abnormalities and GFR comprised between 90 and 60 mL/min
- group 2: GFR comprised between 60 and 30 mL/min
- group 3: GFR <30 mL/min but without dialysis therapy
Who cannot join
- Chronic renal failure patient requiring dialysis therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Risk Factors and Coronary Calcifications in Chronic Renal Failure Patients: Identification of Specific Factors Linked to Renal Failure Progression
The aim of this study is to appreciate the influence of renal failure progression on vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular risk factors.
Read the detailed description
The aim of this study is to appreciate the relationship between:
- extension of coronary calcifications and chronic renal failure progression
- extension of coronary calcifications and levels of osteoprotegerin (bone disease marker)
- cardiovascular risk factors and coronary calcifications
- cardiovascular risk factors and existence of cardiovascular diseases
- Conditions
- Chronic Renal Failure
- Keywords
- Chronic renal failure, Vasculopathy, Cardiovascular risk, Chronic renal failure patients
- Medical subject headings
- Kidney Failure, Chronic, Vascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
description of osteoprotegerin levels according to chronic renal failure progression
Measured: inclusion
Secondary outcomes (4)
calcium score description according to chronic renal failure progression
Measured: inclusion
osteoprotegerin description according to calcium score
Measured: inclusion
relationship between cardiovascular risk factors and calcium score
Measured: inclusion
relationship between cardiovascular risk factors and cardiovascular disease
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Bernard CANAUD, Pr, Principal investigator, CHU Lapeyronie Montpellier FranceJean-Paul CRISTOL, Pr, Study chair, CHU Lapeyronie Montpellier FranceHélène VERNHET, Pr, Study chair, CHU Arnaud de Villeneuve Montpellier FranceKada KLOUCHE, Dr, Study chair, CHU Lapeyronie Montpellier FranceHélène LERAY-MORAGUES, Dr, Study chair, CHU Lapeyronie Montpellier France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608998
- Sponsor's protocol ID
- 7853
- Acronym
- Pre-HD
- Status last verified
- Jan 2008
- First submitted
- 23 Jan 2008
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Risk Factors and Coronary Calcifications in Chronic Renal Failure Patients: Identification of Specific Factors Linked to Renal Failure Progression
- ClinicalTrials.gov ID
- NCT00608998
- Acronym / sponsor ID
- Pre-HD / 7853
- Conditions
- Chronic Renal Failure
- Keywords
- Chronic renal failure, Vasculopathy, Cardiovascular risk, Chronic renal failure patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jul 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Feb 2008 (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 appreciate the influence of renal failure progression on vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular risk factors.
Detailed description
The aim of this study is to appreciate the relationship between:
- extension of coronary calcifications and chronic renal failure progression
- extension of coronary calcifications and levels of osteoprotegerin (bone disease marker)
- cardiovascular risk factors and coronary calcifications
- cardiovascular risk factors and existence of cardiovascular diseases
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (6 listed)
- Patient who has signed the written consent form
- Patient aged > 18 and < 90 years
- Chronic renal failure defined by glomerular filtration rate (GFR)
Key exclusion criteria (1 listed)
- Chronic renal failure patient requiring dialysis therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
description of osteoprotegerin levels according to chronic renal failure progression
Time frame: inclusion
4 secondary outcomes
calcium score description according to chronic renal failure progression
Time frame: inclusion
osteoprotegerin description according to calcium score
Time frame: inclusion
relationship between cardiovascular risk factors and calcium score
Time frame: inclusion
relationship between cardiovascular risk factors and cardiovascular disease
Time frame: inclusion
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 Mar 2021.
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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.
Bernard CANAUD, Pr principal investigator
CHU Lapeyronie Montpellier France
Jean-Paul CRISTOL, Pr study chair
CHU Lapeyronie Montpellier France
Hélène VERNHET, Pr study chair
CHU Arnaud de Villeneuve Montpellier France
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 Chronic Renal Failure, run by University Hospital, Montpellier at 1 site in France.
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 6 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 Mar 2021. 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 France. 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?
description of osteoprotegerin levels according to chronic renal failure progression (time frame: inclusion). 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 Mar 2021.