Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients

April 13, 2022 updated by: University Hospital, Montpellier

Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Castelnau Le Lez, France
        • Recruiting
        • Centre Hémodialyse du Lez
        • Contact:
          • Sébastien Deleuze, Dr
        • Sub-Investigator:
          • Sébastien Deleuze, Dr
      • Montpellier, France
        • Recruiting
        • AIDER
      • Montpellier, France
        • Recruiting
        • CHU Montpellier, Nephrology department
      • Nimes, France
        • Recruiting
        • CH Nimes, Nephrology department
        • Contact:
          • Pascal Reboul, Dr
        • Sub-Investigator:
          • Pascal Reboul, Dr
      • Perpignan, France
        • Recruiting
        • CH Perpignan, Nephrology department
        • Contact:
          • Carlos Vela, Dr
        • Sub-Investigator:
          • Carlos Vela, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Biological: Plasma osteoprotegerin level
dosage of plasma osteoprotegerin
Biological: Plasma fibroblast growth factor 23 level
dosage of plasma fibroblast growth factor 23
Procedure: Vascular calcification score
measurement of vascular calcification score by X-ray of the lateral abdominal aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of vascular calcifications during a 2 year follow up according to plasma osteoprotegerin level at inclusion
Time Frame: 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
2 years after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of vascular calcifications during a 2 year follow up according to plasma fibroblast growth factor 23 level at inclusion
Time Frame: 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
2 years after inclusion
Occurence of cardiovascular events during a 2 year follow up
Time Frame: 2 years after inclusion
2 years after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2011

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

February 1, 2027

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF8851

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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