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

University Hospital Center (CHU)

Status: Enrolling

Conditions: Chronic Kidney Disease

Treatments: Biological: Plasma osteoprotegerin level; Procedure: Vascular calcification score; Biological: Plasma fibroblast growth factor 23 level

Study type: Interventional

Funder types: Other

Identifiers

NCT02808572

UF9125

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Cardiovascular risk evaluation

Experimental group

Description:

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

Treatment:

Biological: Plasma fibroblast growth factor 23 level

Biological: Plasma osteoprotegerin level

Procedure: Vascular calcification score