NCT02808572

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
61mo left

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Mar 2013Jun 2031

Study Start

First participant enrolled

March 12, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Expected
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

11 years

First QC Date

June 17, 2016

Last Update Submit

December 31, 2021

Conditions

Chronic Kidney Disease

Keywords

chronic kidney diseasevascular calcificationscardiovascular risk

Outcome Measures

Primary Outcomes (1)

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

    osteoprotegerin will be measured in picomol/L

    7 years after inclusion

Secondary Outcomes (4)

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

    7 years after inclusion

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

    7 years after inclusion

  • Mortality

    7 years after inclusion

  • Kidney functions

    during the 7 year follow-up

Study Arms (1)

Cardiovascular risk evaluation

EXPERIMENTAL

Measurement at inclusion of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 3 year follow-up

Biological: Plasma osteoprotegerin levelBiological: Plasma fibroblast growth factor 23 levelProcedure: Vascular calcification score

Interventions

Plasma osteoprotegerin levelBIOLOGICAL

dosage of plasma osteoprotegerin

Cardiovascular risk evaluation
Plasma fibroblast growth factor 23 levelBIOLOGICAL

dosage of plasma fibroblast growth factor 23

Cardiovascular risk evaluation
Vascular calcification scorePROCEDURE

measurement of vascular calcification score by multidetection computerized tomography

Cardiovascular risk evaluation

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who has signed the written consent form
  • Patient with chronic renal failure defined by glomerular filtration rate (GFR) but without dialysis therapy

You may not qualify if:

  • Pregnancy
  • Patient with chronic renal failure requiring dialysis therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

AIDER

Montpellier, France

RECRUITING

CHU Montpellier, Cardiology department

Montpellier, France

ACTIVE NOT RECRUITING

CHU Montpellier, Endocrinology department

Montpellier, France

RECRUITING

CHU Montpellier, Intensive care unit

Montpellier, France

ACTIVE NOT RECRUITING

CHU Montpellier, Internal medicine department

Montpellier, France

ACTIVE NOT RECRUITING

CHU Montpellier, Nephrology department

Montpellier, France

RECRUITING

AIDER

Saint-Jean-de-VĂ©das, France

NOT YET RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicVascular Calcification

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jean-Paul CRISTOL, Prof

    CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Paul CRISTOL, Prof

CONTACT

+33(0)4 67 33 83 15jp-cristol@chu-montpellier.fr

Marion Morena, PhD

CONTACT

+33(0)4 11 75 98 93m-morenacarrere@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 21, 2016

Study Start

March 12, 2013

Primary Completion

March 1, 2024

Study Completion (Estimated)

June 1, 2031

Last Updated

January 4, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)