Chronic Kidney DiseaseNCT02813642
Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients
A study testing Plasma osteoprotegerin level, Plasma fibroblast growth factor 23 level and Vascular calcification score in people with Chronic Kidney Disease, run by University Hospital, Montpellier at 5 sites in France.
Trial summary
To evaluate the relationships between bone mineral markers levels at dialysis start and vascular calcification progression during a 2 year follow up Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Plasma osteoprotegerin level, Plasma fibroblast growth factor 23 level and Vascular calcification score
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesFrance
- Study dates
- 8 Dec 2011to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient who has signed the written consent form
- Patient with chronic renal failure starting dialysis therapy
Who cannot join
- Pregnancy
- Patient with chronic renal failure not yet on dialysis therapy
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Centre Hémodialyse du Lez
Castelnau-le-Lez
Sébastien Deleuze, Dr
Sébastien Deleuze, Dr
- Recruiting
AIDER
Montpellier
Lotfi Chalabi, Dr
Lotfi Chalabi, Dr
- Recruiting
CHU Montpellier, Nephrology department
Montpellier
Hélène Leray-Moragues, Dr
Hélène Leray-Moragues, Dr
- Recruiting
CH Nimes, Nephrology department
Nîmes
Pascal Reboul, Dr
Pascal Reboul, Dr
- Recruiting
CH Perpignan, Nephrology department
Perpignan
Carlos Vela, Dr
Carlos Vela, Dr
About this study
Official title: Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis
To evaluate the relationships between bone mineral markers levels at dialysis start and vascular calcification progression during a 2 year follow up
- Conditions
- Chronic Kidney Disease
- Being tested
- Plasma osteoprotegerin level, Plasma fibroblast growth factor 23 level, Vascular calcification score
- Keywords
- chronic kidney disease starting dialysis, cardiovascular risk, bone mineral metabolism markers
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma osteoprotegerin levelBiological
dosage of plasma osteoprotegerin
Plasma fibroblast growth factor 23 levelBiological
dosage of plasma fibroblast growth factor 23
Vascular calcification scoreProcedure or surgery
measurement of vascular calcification score by X-ray of the lateral abdominal aorta
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular risk evaluation | Experimental | Measurement of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 2 year follow-up Receives: Biological: Plasma osteoprotegerin level; Biological: Plasma fibroblast growth factor 23 level; Procedure: Vascular calcification score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of vascular calcifications during a 2 year follow up according to plasma osteoprotegerin level at inclusion
osteoprotegerin will be measured in picomol/L; vascular calcifications will be measured at inclusion and after the 2 year follow up
Measured: 2 years after inclusion
Secondary outcomes (2)
Progression of vascular calcifications during a 2 year follow up according to plasma fibroblast growth factor 23 level at inclusion
fibroblast growth factor 23 will be measured in RU/milliliter; vascular calcifications will be measured at inclusion and after the 2 year follow up
Measured: 2 years after inclusion
Occurence of cardiovascular events during a 2 year follow up
Measured: 2 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start8 Dec 2011
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Cristol, Prof, Principal investigator, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813642
- Sponsor's protocol ID
- UF8851
- Status last verified
- Apr 2022
- First submitted
- 20 Jun 2016
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis
- ClinicalTrials.gov ID
- NCT02813642
- Acronym / sponsor ID
- UF8851
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease starting dialysis, cardiovascular risk, bone mineral metabolism markers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 8 Dec 2011 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Jun 2016 (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.
To evaluate the relationships between bone mineral markers levels at dialysis start and vascular calcification progression during a 2 year follow up
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular risk evaluation | Experimental | Biological: Plasma osteoprotegerin level, Biological: Plasma fibroblast growth factor 23 level, Procedure: Vascular calcification scoreMeasurement of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 2 year follow-up |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who has signed the written consent form
- Patient with chronic renal failure starting dialysis therapy
Key exclusion criteria (2 listed)
- Pregnancy
- Patient with chronic renal failure not yet on 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma osteoprotegerin leveldosage of plasma osteoprotegerin | Biological | Cardiovascular risk evaluation |
| Plasma fibroblast growth factor 23 leveldosage of plasma fibroblast growth factor 23 | Biological | Cardiovascular risk evaluation |
| Vascular calcification scoremeasurement of vascular calcification score by X-ray of the lateral abdominal aorta | Procedure or surgery | Cardiovascular risk evaluation |
Primary outcome
Progression of vascular calcifications during a 2 year follow up according to plasma osteoprotegerin level at inclusion
Time frame: 2 years after inclusion
osteoprotegerin will be measured in picomol/L; vascular calcifications will be measured at inclusion and after the 2 year follow up
2 secondary outcomes
Progression of vascular calcifications during a 2 year follow up according to plasma fibroblast growth factor 23 level at inclusion
Time frame: 2 years after inclusion
Occurence of cardiovascular events during a 2 year follow up
Time frame: 2 years after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Jean-Paul Cristol, Prof principal investigator
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma osteoprotegerin level, Plasma fibroblast growth factor 23 level and Vascular calcification score in people with Chronic Kidney Disease, run by University Hospital, Montpellier at 5 sites 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Paul Cristol, Prof (+33(0)4 67 33 83 15, jp-cristol@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of vascular calcifications during a 2 year follow up according to plasma osteoprotegerin level at inclusion (time frame: 2 years after 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 14 Apr 2022.