Evaluating bone mineral metabolism markers as cardiovascular risk factors in chronic kidney disease patients
New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis
This study is testing if certain bone health markers can help predict heart problems in people with chronic kidney disease over seven years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 7 sites (Montpellier and 6 other locations) |
| Trial ID | NCT02808572 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the relationship between specific bone mineral metabolism markers, such as osteoprotegerin and fibroblast growth factor 23, and the occurrence of cardiovascular events in patients with chronic kidney disease over a 7-year follow-up period. By measuring plasma levels of these markers and vascular calcification scores, the study seeks to identify potential cardiovascular risks associated with chronic renal failure. The findings could help in understanding how bone metabolism influences cardiovascular health in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with chronic kidney disease who are not on dialysis and have provided written consent.
Not a fit: Patients who are pregnant or require dialysis therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for cardiovascular events in patients with chronic kidney disease.
How similar studies have performed: While the specific approach of this study may be novel, there is existing research indicating that biomarkers related to bone metabolism can influence cardiovascular risk in chronic kidney disease patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * Pregnancy * Patient with chronic renal failure requiring dialysis therapy
Where this trial is running
Montpellier and 6 other locations
- 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-Védas, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Jean-Paul CRISTOL, Prof — CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
- Study coordinator: Jean-Paul CRISTOL, Prof
- Email: jp-cristol@chu-montpellier.fr
- Phone: +33(0)4 67 33 83 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.