Clinical trial NCT03996746: Evaluation of Serum Klotho as a Predictor of Progression of Cardiovascular Calcification in Chronic Kidney Disease
Official title: Prospective Evaluation of Serum Klotho, a Novel Biomarker, as a Predictor of Progression of Cardiovascular Calcification (CVC) in Chronic Kidney Disease (CKD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Keywords: Klotho
Cardiovascular Calcification
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two different populations will be selected. First group will be non-dialysis patients with CKD 2-5. Second group will be patients with CKD 5 under hemodialysis for more than 3 months.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The relationship between CVC and serum Klotho
timeFrame: From date of enrollment until the end of study, assessed up to 24 months
Secondary outcomes:
measure: The sensitivity and specificity of serum Klotho in the detection of CVC
timeFrame: From date of enrollment until the end of study, assessed up to 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Wei LU
role: PRINCIPAL_INVESTIGATOR
References: