Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients

NCT ID: NCT02813642

Last Updated: 2022-04-14

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-08

Study Completion Date

2027-02-28

Brief Summary

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To evaluate the relationships between bone mineral markers levels at dialysis start and vascular calcification progression during a 2 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 of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 2 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 X-ray of the lateral abdominal aorta

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 X-ray of the lateral abdominal aorta

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient who has signed the written consent form
* Patient with chronic renal failure starting dialysis therapy

Exclusion Criteria

* Pregnancy
* Patient with chronic renal failure not yet on dialysis therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 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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Centre Hémodialyse du Lez

Castelnau-le-Lez, , France

Site Status RECRUITING

AIDER

Montpellier, , France

Site Status RECRUITING

CHU Montpellier, Nephrology department

Montpellier, , France

Site Status RECRUITING

CH Nimes, Nephrology department

Nîmes, , France

Site Status RECRUITING

CH Perpignan, Nephrology department

Perpignan, , France

Site Status 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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Sébastien Deleuze, Dr

Role: primary

Lotfi Chalabi, Dr

Role: primary

Hélène Leray-Moragues, Dr

Role: primary

Pascal Reboul, Dr

Role: primary

Carlos Vela, Dr

Role: primary

Other Identifiers

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UF8851

Identifier Type: -

Identifier Source: org_study_id

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