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

Not Applicable

Recruiting

• Conditions: Chronic Kidney Disease

• 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

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, Intensive care unit; 🇫🇷 Montpellier, France

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

CHU Montpellier, Nephrology department; 🇫🇷 Montpellier, France