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

Primary Purpose

Chronic Kidney Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Plasma osteoprotegerin level
Plasma fibroblast growth factor 23 level
Vascular calcification score
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Disease focused on measuring chronic kidney disease, vascular calcifications, cardiovascular risk

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AIDERRecruiting
  • CHU Montpellier, Cardiology department
  • CHU Montpellier, Endocrinology departmentRecruiting
  • CHU Montpellier, Intensive care unit
  • CHU Montpellier, Internal medicine department
  • CHU Montpellier, Nephrology departmentRecruiting
  • AIDER

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiovascular risk evaluation

Arm Description

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

Outcomes

Primary Outcome Measures

Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at 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
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
Mortality
Kidney functions
values of creatinine

Full Information

First Posted
June 17, 2016
Last Updated
December 31, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02808572
Brief Title
New Biomarkers of Bone Mineral Metabolism as Cardiovascular Risk Factors in Chronic Kidney Disease Patients
Official Title
New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2013 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease, vascular calcifications, cardiovascular risk

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiovascular risk evaluation
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Plasma osteoprotegerin level
Intervention Description
dosage of plasma osteoprotegerin
Intervention Type
Biological
Intervention Name(s)
Plasma fibroblast growth factor 23 level
Intervention Description
dosage of plasma fibroblast growth factor 23
Intervention Type
Procedure
Intervention Name(s)
Vascular calcification score
Intervention Description
measurement of vascular calcification score by multidetection computerized tomography
Primary Outcome Measure Information:
Title
Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at inclusion
Description
osteoprotegerin will be measured in picomol/L
Time Frame
7 years after inclusion
Secondary Outcome Measure Information:
Title
Occurence of at least one cardiovascular event during the 7 year follow-up according to fibroblast growth factor 23 level at inclusion
Description
fibroblast growth factor 23 will be measured in RU/milliliter
Time Frame
7 years after inclusion
Title
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
Title
Mortality
Time Frame
7 years after inclusion
Title
Kidney functions
Description
values of creatinine
Time Frame
during the 7 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Paul CRISTOL, Prof
Phone
+33(0)4 67 33 83 15
Email
jp-cristol@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Morena, PhD
Phone
+33(0)4 11 75 98 93
Email
m-morenacarrere@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul CRISTOL, Prof
Organizational Affiliation
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIDER
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lotfi Chalabi, Dr
First Name & Middle Initial & Last Name & Degree
Lotfi Chalabi, Dr
Facility Name
CHU Montpellier, Cardiology department
City
Montpellier
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Montpellier, Endocrinology department
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Renard, Prof
First Name & Middle Initial & Last Name & Degree
Eric Renard, Prof
Facility Name
CHU Montpellier, Intensive care unit
City
Montpellier
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Montpellier, Internal medicine department
City
Montpellier
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Montpellier, Nephrology department
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Leray-Moragues, Dr
First Name & Middle Initial & Last Name & Degree
Hélène Leray-Moragues, Dr
First Name & Middle Initial & Last Name & Degree
Leila Chenine, Dr
Facility Name
AIDER
City
Saint-Jean-de-Védas
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie BONNET
Email
m.bonnet@aidersante.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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