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Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients

Primary Purpose

Chronic Kidney Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Plasma osteoprotegerin level
Plasma fibroblast growth factor 23 level
Vascular calcification score
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Disease focused on measuring chronic kidney disease starting dialysis, cardiovascular risk, bone mineral metabolism markers

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hémodialyse du LezRecruiting
  • AIDERRecruiting
  • CHU Montpellier, Nephrology departmentRecruiting
  • CH Nimes, Nephrology departmentRecruiting
  • CH Perpignan, Nephrology departmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiovascular risk evaluation

Arm Description

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

Outcomes

Primary Outcome Measures

Progression of vascular calcifications during a 2 year follow up according to plasma osteoprotegerin level at 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

Progression of vascular calcifications during a 2 year follow up according to plasma fibroblast growth factor 23 level at 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
Occurence of cardiovascular events during a 2 year follow up

Full Information

First Posted
June 20, 2016
Last Updated
April 13, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02813642
Brief Title
Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients
Official Title
Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2011 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease starting dialysis, cardiovascular risk, bone mineral metabolism markers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiovascular risk evaluation
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Plasma osteoprotegerin level
Intervention Description
dosage of plasma osteoprotegerin
Intervention Type
Biological
Intervention Name(s)
Plasma fibroblast growth factor 23 level
Intervention Description
dosage of plasma fibroblast growth factor 23
Intervention Type
Procedure
Intervention Name(s)
Vascular calcification score
Intervention Description
measurement of vascular calcification score by X-ray of the lateral abdominal aorta
Primary Outcome Measure Information:
Title
Progression of vascular calcifications during a 2 year follow up according to plasma osteoprotegerin level at inclusion
Description
osteoprotegerin will be measured in picomol/L; vascular calcifications will be measured at inclusion and after the 2 year follow up
Time Frame
2 years after inclusion
Secondary Outcome Measure Information:
Title
Progression of vascular calcifications during a 2 year follow up according to plasma fibroblast growth factor 23 level at inclusion
Description
fibroblast growth factor 23 will be measured in RU/milliliter; vascular calcifications will be measured at inclusion and after the 2 year follow up
Time Frame
2 years after inclusion
Title
Occurence of cardiovascular events during a 2 year follow up
Time Frame
2 years after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Paul Cristol, Prof
Phone
+33(0)4 67 33 83 15
Email
jp-cristol@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Morena, PhD
Phone
+33(0)4 11 75 98 93
Email
m-morenacarrere@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Cristol, Prof
Organizational Affiliation
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hémodialyse du Lez
City
Castelnau Le Lez
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Deleuze, Dr
First Name & Middle Initial & Last Name & Degree
Sébastien Deleuze, Dr
Facility Name
AIDER
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lotfi Chalabi, Dr
First Name & Middle Initial & Last Name & Degree
Lotfi Chalabi, Dr
Facility Name
CHU Montpellier, Nephrology department
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Leray-Moragues, Dr
First Name & Middle Initial & Last Name & Degree
Hélène Leray-Moragues, Dr
First Name & Middle Initial & Last Name & Degree
Leila Chenine, Dr
Facility Name
CH Nimes, Nephrology department
City
Nimes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Reboul, Dr
First Name & Middle Initial & Last Name & Degree
Pascal Reboul, Dr
Facility Name
CH Perpignan, Nephrology department
City
Perpignan
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Vela, Dr
First Name & Middle Initial & Last Name & Degree
Carlos Vela, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients

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