Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients

Not Applicable

Recruiting

• Conditions: Chronic Kidney Disease
• Interventions: Biological: Plasma osteoprotegerin level; Biological: Plasma fibroblast growth factor 23 level; Procedure: Vascular calcification score

• Registration Number: NCT02813642
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

To evaluate the relationships between bone mineral markers levels at dialysis start and vascular calcification progression during a 2 year follow up

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-08
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14
• Primary Completion: 2026-12
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiovascular risk evaluation	Plasma osteoprotegerin level	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
Cardiovascular risk evaluation	Vascular calcification score	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
Cardiovascular risk evaluation	Plasma fibroblast growth factor 23 level	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

Primary Outcome Measures

Name	Time	Method
Progression of vascular calcifications during a 2 year follow up according to plasma osteoprotegerin level at inclusion	2 years after inclusion	osteoprotegerin will be measured in picomol/L; vascular calcifications will be measured at inclusion and after the 2 year follow up

Secondary Outcome Measures

Name	Time	Method
Occurence of cardiovascular events during a 2 year follow up	2 years after inclusion
Progression of vascular calcifications during a 2 year follow up according to plasma fibroblast growth factor 23 level at inclusion	2 years after inclusion	fibroblast growth factor 23 will be measured in RU/milliliter; vascular calcifications will be measured at inclusion and after the 2 year follow up

Trial Locations

Locations (5)

Centre Hémodialyse du Lez; 🇫🇷 Castelnau Le Lez, France

CH Nimes, Nephrology department; 🇫🇷 Nimes, France

CH Perpignan, Nephrology department; 🇫🇷 Perpignan, France

CHU Montpellier, Nephrology department; 🇫🇷 Montpellier, France

AIDER; 🇫🇷 Montpellier, France