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NCT Number: NCT02808572

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

To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin, fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a 7 year follow-up.

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Key information

Conditions

Chronic Kidney Disease Calcinosis Calcium Metabolism Disorders Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Calcification

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AIDER, Montpellier, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma osteoprotegerin level

Biological

dosage of plasma osteoprotegerin

Plasma fibroblast growth factor 23 level

Biological

dosage of plasma fibroblast growth factor 23

Vascular calcification score

Procedure

measurement of vascular calcification score by multidetection computerized tomography

Primary outcomes

  1. Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at inclusion

    Time frame: 7 years after inclusion

    osteoprotegerin will be measured in picomol/L

Secondary outcomes

  1. Occurence of at least one cardiovascular event during the 7 year follow-up according to fibroblast growth factor 23 level at inclusion

    Time frame: 7 years after inclusion

    fibroblast growth factor 23 will be measured in RU/milliliter

  2. Occurence of at least one cardiovascular event during the 7 year follow-up according to vascular calcification score at inclusion

    Time frame: 7 years after inclusion

  3. Mortality

    Time frame: 7 years after inclusion

  4. Kidney functions

    Time frame: during the 7 year follow-up

    values of creatinine

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Paul CRISTOL, Prof

CONTACT

[email protected]

+33(0)4 67 33 83 15

Marion Morena, PhD

CONTACT

[email protected]

+33(0)4 11 75 98 93

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis

Important dates

Study start
2013
Primary completion
2024
Study completion
2031
First posted
Jun 21, 2016
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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