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Clinical Trials/NCT02808572
NCT02808572RecruitingNot Applicable

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

University Hospital, Montpellier7 sites in 1 country250 target enrollmentStarted: March 12, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
250
Locations
7
Primary Endpoint
Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at inclusion
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 95 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (7)

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