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)
1 other identifier
observational
700
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedStudy Start
First participant enrolled
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 28, 2020
August 1, 2020
2.3 years
June 23, 2019
August 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
Non-dialysis Group
non-dialysis patients with CKD 2-5
Hemodialysis Group
patients with CKD 5 under hemodialysis for more than 3 months
Interventions
Eligibility Criteria
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.
You may qualify if:
- age over 18 years old, regardless of gender
- non-dialysis patients with CKD 2-5, or patients with CKD 5 under hemodialysis for more than 3 months
You may not qualify if:
- life expectancy \< 2 years
- severe complications of heart, lung, liver or brain
- primary hyperparathyroidism
- malignant tumor
- pregnant or breastfeeding
- contraindications to CT examination
- unwilling or unable to comply with the research protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei LU
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2019
First Posted
June 25, 2019
Study Start
June 25, 2019
Primary Completion
September 30, 2021
Study Completion
December 31, 2021
Last Updated
August 28, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share