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Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813642
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis
Actual Study Start Date : December 8, 2011
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. Occurence of cardiovascular events during a 2 year follow up [ Time Frame: 2 years after inclusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 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 starting dialysis therapy

Exclusion Criteria:

  • Pregnancy
  • Patient with chronic renal failure not yet on 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): NCT02813642


Contacts
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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
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France
Centre Hémodialyse du Lez Recruiting
Castelnau Le Lez, France
Contact: Sébastien Deleuze, Dr         
Sub-Investigator: Sébastien Deleuze, Dr         
AIDER Recruiting
Montpellier, France
Contact: Lotfi Chalabi, Dr         
Sub-Investigator: Lotfi Chalabi, Dr         
CHU Montpellier, Nephrology department Recruiting
Montpellier, France
Contact: Hélène Leray-Moragues, Dr         
Sub-Investigator: Hélène Leray-Moragues, Dr         
Sub-Investigator: Leila Chenine, Dr         
CH Nimes, Nephrology department Recruiting
Nimes, France
Contact: Pascal Reboul, Dr         
Sub-Investigator: Pascal Reboul, Dr         
CH Perpignan, Nephrology department Recruiting
Perpignan, France
Contact: Carlos Vela, Dr         
Sub-Investigator: Carlos Vela, Dr         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Jean-Paul Cristol, Prof CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02813642    
Other Study ID Numbers: UF8851
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Montpellier:
chronic kidney disease starting dialysis
cardiovascular risk
bone mineral metabolism markers
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action