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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Chronic Kidney Disease

Treatments: Diagnostic Test: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03996746

XH-19-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

700 participants in 2 patient groups

Non-dialysis Group

Description:

non-dialysis patients with CKD 2-5

Treatment:

Diagnostic Test: No intervention

Hemodialysis Group

Description:

patients with CKD 5 under hemodialysis for more than 3 months

Treatment:

Diagnostic Test: No intervention