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RecruitingNCT02808572Updated Jan 4, 2022

New Biomarkers of Bone Mineral Metabolism as Cardiovascular Risk Factors in Chronic Kidney Disease Patients

An interventional study of Plasma osteoprotegerin level and Plasma fibroblast growth factor 23 level in Chronic Kidney Disease, sponsored by University Hospital, Montpellier. Recruiting at 7 sites in France. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2022-01-04.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Registered 3 years 3 months after the study started (first participant enrolled Mar 2013, registered Jun 2016).
  • Started Mar 2013; still recruiting 13 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
18 Years to 95 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • chronic kidney disease
  • vascular calcifications
  • cardiovascular risk
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 250 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Patient with chronic renal failure requiring dialysis therapy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Cardiovascular risk evaluation

    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 level · Biological: Plasma fibroblast growth factor 23 level · Procedure: Vascular calcification score

Interventions

  • BiologicalPlasma osteoprotegerin level

    dosage of plasma osteoprotegerin

  • BiologicalPlasma fibroblast growth factor 23 level

    dosage of plasma fibroblast growth factor 23

  • ProcedureVascular calcification score

    measurement of vascular calcification score by multidetection computerized tomography

06

What researchers measure

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

    Time frame: 7 years after inclusion

Secondary outcomes

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

    fibroblast growth factor 23 will be measured in RU/milliliter

    Time frame: 7 years after inclusion

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

    Time frame: 7 years after inclusion

  3. Mortality

    Time frame: 7 years after inclusion

  4. Kidney functions

    values of creatinine

    Time frame: during the 7 year follow-up

07

Study locations

3 of 7 sites recruiting
  • AIDER
    Montpellier, France
    • Lotfi Chalabi, Dr · Contact
    • Lotfi Chalabi, Dr · Sub investigator
    Recruiting
  • CHU Montpellier, Cardiology department
    Montpellier, France
    Active, not recruiting
  • CHU Montpellier, Endocrinology department
    Montpellier, France
    • Eric Renard, Prof · Contact
    • Eric Renard, Prof · Sub investigator
    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
    • Hélène Leray-Moragues, Dr · Contact
    • Hélène Leray-Moragues, Dr · Sub investigator
    • Leila Chenine, Dr · Sub investigator
    Recruiting
  • AIDER
    Saint-Jean-de-Védas, France
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02808572
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Jun 21, 2016
Start date
Mar 12, 2013
Primary completion
Mar 2024 (estimated)
Completion
Jun 2031 (estimated)
Last update
Jan 4, 2022

Study contacts

Jean-Paul CRISTOL, Prof
Contact
jp-cristol@chu-montpellier.fr
+33(0)4 67 33 83 15
Marion Morena, PhD
Contact
m-morenacarrere@chu-montpellier.fr
+33(0)4 11 75 98 93
Jean-Paul CRISTOL, Prof
principal investigator · CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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