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NCT02808572 Clinical Trial

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

Chronic Kidney Disease Clinical Trial

Official title:
New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02808572
Other study ID # UF9125
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 12, 2013
Est. completion date June 2031

Study information
Verified date December 2021
Source University Hospital, Montpellier
Contact Jean-Paul CRISTOL, Prof
Phone +33(0)4 67 33 83 15
Email jp-cristol@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date June 2031
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Plasma osteoprotegerin level
dosage of plasma osteoprotegerin
• Plasma fibroblast growth factor 23 level
dosage of plasma fibroblast growth factor 23
Procedure:
• Vascular calcification score
measurement of vascular calcification score by multidetection computerized tomography

Locations
Country Name City State
France AIDER Montpellier
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 AIDER Saint-Jean-de-Védas

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at inclusion osteoprotegerin will be measured in picomol/L 7 years after inclusion
Secondary Occurence of at least one cardiovascular event during the 7 year follow-up according to fibroblast growth factor 23 level at inclusion fibroblast growth factor 23 will be measured in RU/milliliter 7 years after inclusion
Secondary Occurence of at least one cardiovascular event during the 7 year follow-up according to vascular calcification score at inclusion 7 years after inclusion
Secondary Mortality 7 years after inclusion
Secondary Kidney functions values of creatinine during the 7 year follow-up
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