New Biomarkers of Bone Mineral Metabolism as Cardiovascular Risk Factors in Chronic Kidney Disease Patients

Not Applicable

Recruiting

• Conditions: Chronic Kidney Disease
• Interventions: Biological: Plasma osteoprotegerin level; Biological: Plasma fibroblast growth factor 23 level; Procedure: Vascular calcification score

• Registration Number: NCT02808572
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin, fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a 7 year follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-12
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-21
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-31
• Last Update Posted: 2022-01-04
• Primary Completion: 2024-03
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Patient who has signed the written consent form
• Patient with chronic renal failure defined by glomerular filtration rate (GFR) but without dialysis therapy

Exclusion Criteria

• Pregnancy
• Patient with chronic renal failure requiring dialysis therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiovascular risk evaluation	Vascular calcification score	Measurement at inclusion of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 3 year follow-up
Cardiovascular risk evaluation	Plasma osteoprotegerin level	Measurement at inclusion of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 3 year follow-up
Cardiovascular risk evaluation	Plasma fibroblast growth factor 23 level	Measurement at inclusion of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 3 year follow-up

Primary Outcome Measures

Name	Time	Method
Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at inclusion	7 years after inclusion	osteoprotegerin will be measured in picomol/L

Secondary Outcome Measures

Name	Time	Method
Mortality	7 years after inclusion
Occurence of at least one cardiovascular event during the 7 year follow-up according to fibroblast growth factor 23 level at inclusion	7 years after inclusion	fibroblast growth factor 23 will be measured in RU/milliliter
Occurence of at least one cardiovascular event during the 7 year follow-up according to vascular calcification score at inclusion	7 years after inclusion
Kidney functions	during the 7 year follow-up	values of creatinine

Trial Locations

Locations (6)

AIDER; 🇫🇷 Saint-Jean-de-Védas, France

CHU Montpellier, Cardiology department; 🇫🇷 Montpellier, France

CHU Montpellier, Endocrinology department; 🇫🇷 Montpellier, France

CHU Montpellier, Internal medicine department; 🇫🇷 Montpellier, France

CHU Montpellier, Nephrology department; 🇫🇷 Montpellier, France

CHU Montpellier, Intensive care unit; 🇫🇷 Montpellier, France