Chronic Kidney Disease Mineral and Bone Disorder Clinical Trial
Official title:
Artificial Intelligence: to Analyse CKD-MBD in Hemodialysis and Cardiovascular Risk
Verified date | December 2018 |
Source | Maimónides Biomedical Research Institute of Córdoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The regulation of calcium, phosphate and parathyroid hormone in hemodialysis is complex and each parameter is not independently regulated. Simultaneous modification in these three parameters are the result of abnormal mineral metabolism and the treatment used. The specific objective of this work is an accurate and exhaustive analysis and description of the complex relationships between clinically relevant parameters in chronic kidney disease metabolism bone disease. In order to achieve these objectives we have used a machine learning approach Random Forest able to extract useful knowledge from a large database. The analysis of the complex interactions between the different parameters needs an advance mathematical approach such as Random Forest . The second aim of this study is to determine whether calcium, phosphate and parathyroid hormone, Fibroblast growth factor 23 and calcitriol are long-term associated with demographic features, mortality, co-morbidity and the therapy prescribed. We will analyze in a prospective study on incident patients, whether the use of this new model may predict the cardiovascular risk..
Status | Completed |
Enrollment | 197 |
Est. completion date | December 19, 2018 |
Est. primary completion date | December 19, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Incident hemodialysis patients - Non acute renal failure Exclusion Criteria: - Previous treatment with cinacalcet - Neoplasia - Previous parathyrodectomy |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Reina Sofía | Córdoba |
Lead Sponsor | Collaborator |
---|---|
Maimónides Biomedical Research Institute of Córdoba |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Fibroblast growth factor 23 (pg/ml) at 24 months | Prospective analysis of fibroblast growth factor in a cohort of incident hemodialysis patients | Baseline, 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03960437 -
The Effect of Etelcalcetide on CKD-MBD
|
Phase 2 | |
Completed |
NCT03937349 -
Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients
|
||
Completed |
NCT03626246 -
Pathogenesis of Compromised Bone Quality and Mechanics in Chronic Kidney Disease
|
||
Active, not recruiting |
NCT03285854 -
Calcium Balance Studies in Children With CKD and on Dialysis
|
||
Active, not recruiting |
NCT04019379 -
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
|
N/A | |
Active, not recruiting |
NCT03108222 -
Phosphorus Absorption in Healthy Adults and in Patients With Moderate Chronic Kidney Disease
|