Evaluation of Serum Klotho as a Predictor of Progression of Cardiovascular Calcification in Chronic Kidney Disease

Study Overview
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Brief Summary
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This prospective observational study aims to investigate the relationship between CVC and serum Klotho for renal function correction in patients with different CKD stages

Detailed Description
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In this study, we plan to enroll 400 non-dialysis patients with CKD 2-5 and 300 maintenance hemodialysis patients. Participants will receive coronary artery computed tomography (CT) scanning to detect the extent and the severity of CVC. Follow-up is scheduled at 0, 6, 12, 18, and 24 months and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/kidney functions, tests of the coagulation system, etc.), total calcium, phosphate, parathyroid hormone (PTH), serum 25(OH) vitamin D, fibroblast growth factor-23 (FGF-23) and coronary artery computed tomography (CT). The purpose of this study was to clarify the relationship between CVC in patients with different CKD stages and serum Klotho for renal function correction, and to clarify that Klotho can be used as an early biomarker for CVC in patients with CKD, so as to predict the occurrence and progress of CVC.

Official Title
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Prospective Evaluation of Serum Klotho, a Novel Biomarker, as a Predictor of Progression of Cardiovascular Calcification (CVC) in Chronic Kidney Disease (CKD)

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Diagnostic Test: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 years old, regardless of gender non-dialysis patients with CKD 2-5, or patients with CKD 5 under hemodialysis for more than 3 months Exclusion Criteria: life expectancy < 2 years severe complications of heart, lung, liver or brain primary hyperparathyroidism malignant tumor pregnant or breastfeeding contraindications to CT examination unwilling or unable to comply with the research protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-dialysis Group<br>non-dialysis patients with CKD 2-5 | Diagnostic Test: No intervention<br>* No intervention<br>|
| Hemodialysis Group<br>patients with CKD 5 under hemodialysis for more than 3 months | Diagnostic Test: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between CVC and serum Klotho | To clarify the relationship between CVC and serum Klotho for renal function correction in patients with different CKD stages, and to clarify that Klotho can be used as an early biomarker for CVC in patients with CKD, so as to predict the occurrence and progress of CVC | From date of enrollment until the end of study, assessed up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of serum Klotho in the detection of CVC | To evaluate the sensitivity and specificity of serum Klotho in the detection of cardiovascular calcification and to clarify its status as a biomarker of calcification | From date of enrollment until the end of study, assessed up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Klotho, Cardiovascular Calcification