Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients
Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis
1 other identifier
interventional
400
1 country
5
Brief Summary
To evaluate the relationships between bone mineral markers levels at dialysis start and vascular calcification progression during a 2 year follow up
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 8, 2011
CompletedFirst Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
April 14, 2022
April 1, 2022
15 years
June 20, 2016
April 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
2 years after inclusion
Occurence of cardiovascular events during a 2 year follow up
2 years after inclusion
Study Arms (1)
Cardiovascular risk evaluation
EXPERIMENTALMeasurement of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 2 year follow-up
Interventions
dosage of plasma osteoprotegerin
dosage of plasma fibroblast growth factor 23
measurement of vascular calcification score by X-ray of the lateral abdominal aorta
Eligibility Criteria
You may qualify if:
- Patient who has signed the written consent form
- Patient with chronic renal failure starting dialysis therapy
You may not qualify if:
- Pregnancy
- Patient with chronic renal failure not yet on dialysis therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Centre Hémodialyse du Lez
Castelnau-le-Lez, France
AIDER
Montpellier, France
CHU Montpellier, Nephrology department
Montpellier, France
CH Nimes, Nephrology department
Nîmes, France
CH Perpignan, Nephrology department
Perpignan, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Paul Cristol, Prof
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2016
First Posted
June 27, 2016
Study Start
December 8, 2011
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
April 14, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share