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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT02808572

Collaborator

(none)

250

Enrollment

Locations

Arm

218.6

Anticipated Duration (Months)

35.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Biological: Plasma osteoprotegerin level Biological: Plasma fibroblast growth factor 23 level Procedure: Vascular calcification score	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 12, 2013

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardiovascular risk evaluation 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	Biological: Plasma osteoprotegerin level dosage of plasma osteoprotegerin Biological: 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

Arm

Intervention/Treatment

Experimental: Cardiovascular risk evaluation

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

Biological: Plasma osteoprotegerin level

dosage of plasma osteoprotegerin

Biological: 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

Outcome Measures

Primary Outcome Measures

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

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]
Mortality [7 years after inclusion]
Kidney functions [during the 7 year follow-up]
values of creatinine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	AIDER	Montpellier	France
2	CHU Montpellier, Cardiology department	Montpellier	France
3	CHU Montpellier, Endocrinology department	Montpellier	France
4	CHU Montpellier, Intensive care unit	Montpellier	France
5	CHU Montpellier, Internal medicine department	Montpellier	France
6	CHU Montpellier, Nephrology department	Montpellier	France
7	AIDER	Saint-Jean-de-Védas	France