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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine700 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

700

Conditions

Chronic Kidney Disease

Interventions

No interventionDIAGNOSTIC_TEST

No intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age over 18 years old, regardless of gender 2. non-dialysis patients with CKD 2-5, or patients with CKD 5 under hemodialysis for more than 3 months Exclusion Criteria: 1. life expectancy \< 2 years 2. severe complications of heart, lung, liver or brain 3. primary hyperparathyroidism 4. malignant tumor 5. pregnant or breastfeeding 6. contraindications to CT examination 7. unwilling or unable to comply with the research protocol

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: From date of enrollment until the end of study, assessed up to 24 months

Secondary Outcomes

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

Time frame: From date of enrollment until the end of study, assessed up to 24 months

Central Contacts

Wei LU

CONTACT

+86-13651608106 luweixh@126.com

Data from ClinicalTrials.gov

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