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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02697578
Other study ID # PI-0311-2014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2016
Est. completion date December 19, 2018

Study information

Verified date December 2018
Source Maimónides Biomedical Research Institute of Córdoba
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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..


Description:

In hemodialysis patients, deviations of serum concentration of calcium, phosphate or parathyroid hormone from the values recommended by KDIGO are associated to a negative outcome. The regulation of calcium, phosphate and parathyroid hormone is complex and each parameter is not independently regulated. In hemodialysis patient's simultaneous modification in these three parameters are the result of abnormal mineral metabolism and the treatment used to correct these abnormalities that usually produce changes in more than one parameter. 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. Compare the predictions obtained with conventional statistical analysis versus the new model analysis based on artificial intelligence. Our preliminary results suggest that there are interactions between some parameters that are strong enough to question whether the evaluation of a given therapy can be based in the measurement of one single parameter. Subsequently, we will analyze in a prospective study on incident patients, whether the use of this new model may predict the cardiovascular risk and reduce the therapy cost.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Spain Hospital Universitario Reina Sofía Córdoba

Sponsors (1)

Lead Sponsor Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

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
See also
  Status Clinical Trial Phase
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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