Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients

Not Applicable

Recruiting

• Conditions: Chronic Kidney Disease

• 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

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

AIDER; 🇫🇷 Montpellier, France

CHU Montpellier, Nephrology department; 🇫🇷 Montpellier, France

CH Nimes, Nephrology department; 🇫🇷 Nimes, France

CH Perpignan, Nephrology department; 🇫🇷 Perpignan, France