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

NCT ID: NCT02808572

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-12

Study Completion Date

2031-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Plasma osteoprotegerin level

Intervention Type BIOLOGICAL

dosage of plasma osteoprotegerin

Plasma fibroblast growth factor 23 level

Intervention Type BIOLOGICAL

dosage of plasma fibroblast growth factor 23

Vascular calcification score

Intervention Type PROCEDURE

measurement of vascular calcification score by multidetection computerized tomography

Interventions

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Plasma osteoprotegerin level

dosage of plasma osteoprotegerin

Intervention Type BIOLOGICAL

Plasma fibroblast growth factor 23 level

dosage of plasma fibroblast growth factor 23

Intervention Type BIOLOGICAL

Vascular calcification score

measurement of vascular calcification score by multidetection computerized tomography

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Paul CRISTOL, Prof

Role: PRINCIPAL_INVESTIGATOR

CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

Locations

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AIDER

Montpellier, , France

Site Status RECRUITING

CHU Montpellier, Cardiology department

Montpellier, , France

Site Status ACTIVE_NOT_RECRUITING

CHU Montpellier, Endocrinology department

Montpellier, , France

Site Status RECRUITING

CHU Montpellier, Intensive care unit

Montpellier, , France

Site Status ACTIVE_NOT_RECRUITING

CHU Montpellier, Internal medicine department

Montpellier, , France

Site Status ACTIVE_NOT_RECRUITING

CHU Montpellier, Nephrology department

Montpellier, , France

Site Status RECRUITING

AIDER

Saint-Jean-de-Védas, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Jean-Paul CRISTOL, Prof

Role: CONTACT

+33(0)4 67 33 83 15

Marion Morena, PhD

Role: CONTACT

+33(0)4 11 75 98 93

Facility Contacts

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Lotfi Chalabi, Dr

Role: primary

Eric Renard, Prof

Role: primary

Hélène Leray-Moragues, Dr

Role: primary

Marie BONNET

Role: primary

Other Identifiers

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UF9125

Identifier Type: -

Identifier Source: org_study_id

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