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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03996746
• Other study ID #: XH-19-003
• Status: Recruiting
• Start date: June 25, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2020
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Wei LU
• Phone: +86-13651608106
• Email: luweixh[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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