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

University Hospital, Montpellier6 sites in 1 country250 target enrollmentMarch 12, 2013

ConditionsChronic Kidney Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Kidney Disease
Sponsor: University Hospital, Montpellier
Enrollment: 250
Locations: 6
Primary Endpoint: Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at inclusion
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 12, 2013

End Date

June 2031

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Montpellier

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at inclusion

Time Frame: 7 years after inclusion

osteoprotegerin will be measured in picomol/L

Secondary Outcomes

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)
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)