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Status unknownNCT03996746Updated Aug 28, 2020

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

An observational study in Chronic Kidney Disease, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-28.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
700
Ages
18 Years and older
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Chronic Kidney Disease

Keywords

  • Klotho
  • Cardiovascular Calcification
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 700 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No

Groups and cohorts

  • Non-dialysis Group

    non-dialysis patients with CKD 2-5

    Diagnostic Test: No intervention

  • Hemodialysis Group

    patients with CKD 5 under hemodialysis for more than 3 months

    Diagnostic Test: No intervention

Interventions

  • Diagnostic testNo intervention

    No intervention

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What researchers measure

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

    Time frame: 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

    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

    Time frame: From date of enrollment until the end of study, assessed up to 24 months

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Study locations

1 of 1 sites recruiting
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03996746
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Sponsor
First posted
Jun 25, 2019
Start date
Jun 25, 2019
Primary completion
Sep 30, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Aug 28, 2020

Study contacts

Wei LU
Contact
luweixh@126.com
+86-13651608106
Wei LU
principal investigator · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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