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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

Tracking Information
First Submitted Date  ICMJE June 20, 2016
First Posted Date  ICMJE June 27, 2016
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE December 8, 2011
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
  • 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
  • Occurence of cardiovascular events during a 2 year follow up [ Time Frame: 2 years after inclusion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients
Official Title  ICMJE Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Interventions:
  • Biological: Plasma osteoprotegerin level
  • Biological: Plasma fibroblast growth factor 23 level
  • Procedure: Vascular calcification score
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2016)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02813642
Other Study ID Numbers  ICMJE UF8851
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Paul Cristol, Prof CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
PRS Account University Hospital, Montpellier
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP