Recruiting NCT02813642
Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients
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 →
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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