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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02813642
Other study ID # UF8851
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 8, 2011
Est. completion date February 2027

Study information

Verified date April 2022
Source University Hospital, Montpellier
Contact Jean-Paul Cristol, Prof
Phone +33(0)4 67 33 83 15
Email jp-cristol@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date February 2027
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Intervention

Biological:
Plasma osteoprotegerin level
dosage of plasma osteoprotegerin
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

Locations

Country Name City State
France Centre Hémodialyse du Lez Castelnau Le Lez
France AIDER Montpellier
France CHU Montpellier, Nephrology department Montpellier
France CH Nimes, Nephrology department Nimes
France CH Perpignan, Nephrology department Perpignan

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression of vascular calcifications during a 2 year follow up according to plasma osteoprotegerin level at inclusion osteoprotegerin will be measured in picomol/L; vascular calcifications will be measured at inclusion and after the 2 year follow up 2 years after inclusion
Secondary Progression of vascular calcifications during a 2 year follow up according to plasma fibroblast growth factor 23 level at 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 years after inclusion
Secondary Occurence of cardiovascular events during a 2 year follow up 2 years after inclusion
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