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Recruiting NCT02813642

Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients

No phase Interventional Chronic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plasma osteoprotegerin level, Plasma fibroblast growth factor 23 level, Vascular calcification score.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • 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

  • Progression of vascular calcifications during a 2 year follow up according to plasma osteoprotegerin level at inclusion [Time frame: 2 years after inclusion]
Secondary outcome measures (2)
  • 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]
  • Occurence of cardiovascular events during a 2 year follow up [Time frame: 2 years after inclusion]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 5 centers
  • Centre Hémodialyse du Lez — Castelnau-le-Lez
  • AIDER — Montpellier
  • CHU Montpellier, Nephrology department — Montpellier
  • CH Nimes, Nephrology department — Nîmes
  • CH Perpignan, Nephrology department — Perpignan

Identifiers

NCT: NCT02813642 · UF8851

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗