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New Biomarkers of Bone Mineral Metabolism as Cardiovascular Risk Factors in Chronic Kidney Disease Patients

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ClinicalTrials.gov Identifier: NCT02808572
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin, fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a 3 year follow-up.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Biological: Plasma osteoprotegerin level Biological: Plasma fibroblast growth factor 23 level Procedure: Vascular calcification score Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis
Study Start Date : March 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cardiovascular risk evaluation
Measurement at inclusion of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 3 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 multidetection computerized tomography




Primary Outcome Measures :
  1. Occurence of at least one cardiovascular event during the 3 year follow-up according to osteoprotegerin level at inclusion [ Time Frame: 3 years after inclusion ]
    osteoprotegerin will be measured in picomol/L


Secondary Outcome Measures :
  1. Occurence of at least one cardiovascular event during the 3 year follow-up according to fibroblast growth factor 23 level at inclusion [ Time Frame: 3 years after inclusion ]
    fibroblast growth factor 23 will be measured in RU/milliliter

  2. Occurence of at least one cardiovascular event during the 3 year follow-up according to vascular calcification score at inclusion [ Time Frame: 3 years after inclusion ]
  3. Mortality [ Time Frame: 3 years after inclusion ]


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient who has signed the written consent form
  • Patient with chronic renal failure defined by glomerular filtration rate (GFR) but without dialysis therapy

Exclusion Criteria:

  • Pregnancy
  • Patient with chronic renal failure requiring dialysis therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808572


Contacts
Contact: Jean-Paul CRISTOL, Prof +33(0)4 67 33 83 15 jp-cristol@chu-montpellier.fr
Contact: Marion Morena, PhD +33(0)4 11 75 98 93 m-morenacarrere@chu-montpellier.fr

Locations
France
AIDER Recruiting
Montpellier, France
Contact: Lotfi Chalabi, Dr         
Sub-Investigator: Lotfi Chalabi, Dr         
CHU Montpellier, Cardiology department Active, not recruiting
Montpellier, France
CHU Montpellier, Endocrinology department Recruiting
Montpellier, France
Contact: Eric Renard, Prof         
Sub-Investigator: Eric Renard, Prof         
CHU Montpellier, Intensive care unit Active, not recruiting
Montpellier, France
CHU Montpellier, Internal medicine department Active, not recruiting
Montpellier, France
CHU Montpellier, Nephrology department Recruiting
Montpellier, France
Contact: Hélène Leray-Moragues, Dr         
Sub-Investigator: Hélène Leray-Moragues, Dr         
Sub-Investigator: Leila Chenine, Dr         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Jean-Paul CRISTOL, Prof CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02808572     History of Changes
Other Study ID Numbers: UF9125
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Montpellier:
chronic kidney disease
vascular calcifications
cardiovascular risk

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action