Evaluating cardiovascular risks in patients starting dialysis
Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis
This study is testing how certain bone markers in people starting dialysis for kidney disease might affect their heart health over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 5 sites (Castelnau-le-Lez and 4 other locations) |
| Trial ID | NCT02813642 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the relationship between levels of bone mineral markers and the progression of vascular calcification in patients who are beginning dialysis treatment for chronic kidney disease. Over a two-year follow-up period, researchers will measure plasma osteoprotegerin and fibroblast growth factor 23 levels, as well as vascular calcification scores. The goal is to better understand how these factors contribute to cardiovascular risks in this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with chronic renal failure who are beginning dialysis therapy.
Not a fit: Patients who are pregnant or those with chronic renal failure not yet on dialysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of cardiovascular risks in patients starting dialysis.
How similar studies have performed: Other studies have explored cardiovascular risks in dialysis patients, but this specific approach focusing on bone mineral metabolism markers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Castelnau-le-Lez and 4 other locations
- Centre Hémodialyse du Lez — Castelnau-le-Lez, France (Recruiting)
- Aider — Montpellier, France (Recruiting)
- CHU Montpellier, Nephrology department — Montpellier, France (Recruiting)
- CH Nimes, Nephrology department — Nîmes, France (Recruiting)
- CH Perpignan, Nephrology department — Perpignan, France (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.