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

December 31, 2021 updated by: University Hospital, Montpellier

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France
        • Recruiting
        • AIDER
      • Montpellier, France
        • Active, not recruiting
        • CHU Montpellier, Cardiology department
      • Montpellier, France
        • Recruiting
        • CHU Montpellier, Endocrinology department
        • Contact:
          • Eric Renard, Prof
        • Sub-Investigator:
          • Eric Renard, Prof
      • Montpellier, France
        • Active, not recruiting
        • CHU Montpellier, Intensive care unit
      • Montpellier, France
        • Active, not recruiting
        • CHU Montpellier, Internal medicine department
      • Montpellier, France
        • Recruiting
        • CHU Montpellier, Nephrology department
      • Saint-Jean-de-Védas, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 years after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of at least one cardiovascular event during the 7 year follow-up according to fibroblast growth factor 23 level at inclusion
Time Frame: 7 years after inclusion
fibroblast growth factor 23 will be measured in RU/milliliter
7 years after inclusion
Occurence of at least one cardiovascular event during the 7 year follow-up according to vascular calcification score at inclusion
Time Frame: 7 years after inclusion
7 years after inclusion
Mortality
Time Frame: 7 years after inclusion
7 years after inclusion
Kidney functions
Time Frame: during the 7 year follow-up
values of creatinine
during the 7 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 12, 2013

Primary Completion (ANTICIPATED)

March 1, 2024

Study Completion (ANTICIPATED)

June 1, 2031

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (ESTIMATE)

June 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 31, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF9125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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