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NCT Number: NCT02813642

Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients

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

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hémodialyse du Lez, Castelnau-le-Lez, 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 starting dialysis therapy

Exclusion criteria

  • Pregnancy
  • Patient with chronic renal failure not yet on 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 X-ray of the lateral abdominal aorta

Primary outcomes

  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 outcomes

  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

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

Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis

Important dates

Study start
2011
Primary completion
2026
Study completion
2027
First posted
Jun 27, 2016
Registry last updated
Apr 14, 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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