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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02808572

Enrollment

250

Registered

2016-06-21

Start date

2013-03-12

Completion date

2031-06-30

Last updated

2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease, vascular calcifications, cardiovascular risk

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.

Interventions

BIOLOGICALPlasma osteoprotegerin level

dosage of plasma osteoprotegerin

BIOLOGICALPlasma fibroblast growth factor 23 level

dosage of plasma fibroblast growth factor 23

PROCEDUREVascular calcification score

measurement of vascular calcification score by multidetection computerized tomography

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Contacts

Primary ContactJean-Paul CRISTOL, Prof

jp-cristol@chu-montpellier.fr+33(0)4 67 33 83 15

Backup ContactMarion Morena, PhD

m-morenacarrere@chu-montpellier.fr+33(0)4 11 75 98 93

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026