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

• Conditions: Chronic Kidney Disease
• Interventions: Diagnostic Test: No intervention

• Registration Number: NCT03996746
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-06-23
• Study First Submitted QC: 2019-06-23
• Study Start: 2019-06-25
• Study First Posted: 2019-06-25
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-dialysis Group	No intervention	non-dialysis patients with CKD 2-5
Hemodialysis Group	No intervention	patients with CKD 5 under hemodialysis for more than 3 months

Primary Outcome Measures

Name	Time	Method
The relationship between CVC and serum Klotho	From date of enrollment until the end of study, assessed up to 24 months	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

Secondary Outcome Measures

Name	Time	Method
The sensitivity and specificity of serum Klotho in the detection of CVC	From date of enrollment until the end of study, assessed up to 24 months	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

Trial Locations

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China