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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03996746

Enrollment

700

Registered

2019-06-25

Start date

2019-06-25

Completion date

2021-12-31

Last updated

2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Klotho, Cardiovascular Calcification

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.

Interventions

DIAGNOSTIC_TESTNo intervention

No intervention

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactWei LU

luweixh@126.com+86-13651608106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026