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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014329
Receipt No. R000016681
Scientific Title Serum Cystatin C Is a Significant Diagnostic Marker of the Renal Resistive Index Detected on Doppler Ultrasound in Patients with Chronic Kidney Disease
Date of disclosure of the study information 2014/06/20
Last modified on 2018/09/14

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Basic information
Public title Serum Cystatin C Is a Significant Diagnostic Marker of the Renal Resistive Index Detected on Doppler Ultrasound in Patients with Chronic Kidney Disease
Acronym Diagnostic Marker of the Renal Resistive Index Detected on Doppler Ultrasound in Patients with Chronic Kidney Disease
Scientific Title Serum Cystatin C Is a Significant Diagnostic Marker of the Renal Resistive Index Detected on Doppler Ultrasound in Patients with Chronic Kidney Disease
Scientific Title:Acronym Diagnostic Marker of the Renal Resistive Index Detected on Doppler Ultrasound in Patients with Chronic Kidney Disease
Region
Japan

Condition
Condition Chronic Kidney Disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate whether the serum Cystatin C level is associated with signs of vascular dysfunction such as arterial stiffness, a major determinant of prognosis, in human subjects with chronic kidney disease (CKD).
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between serum Cystain C and Renal Resistive Index
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inpatients
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Sugiyama
Organization Okayama University Graduate School of
Medicine, Dentistry and Pharmaceutical
Sciences
Division name Center for Chronic Kidney Disease and Peritoneal Dialysis
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama
TEL 086-235-7235
Email hitoshis@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayu Akiyama
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama
TEL 086-235-7235
Homepage URL
Email ayu8823@mx31.tiki.ne.jp

Sponsor
Institute Department of Medicine and Clinical
Science, Okayama University Graduate
School of Medicine, Dentistry and
Pharmaceutical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We determined the levels of serum CysC in 83 CKD patients (median age: 57.0 years, male: 67.5%, diabetes: 9.6%).
The serum CysC level was significantly correlated with the renal RI(P < 0.0001) and baPWV(P = 0.0001). The serum CysC level was a significant determinant of the renal RI(P = 0.0006) in a multivariate regression analysis using a biomarker model. The multivariate odds ratio of the serum CysC level for a renal RI of 0.70, a level that predicts worse renal outcomes, was significant (4.00, p = 0.0007). The area under the receiver-operating characteristic curve comparing the sensitivity and specificity of CysC for predicting the RI 0.70 was 0.925 (P < 0.0001) (cutoff value: 2.04 mg/L).

Management information
Registered date
2014 Year 06 Month 20 Day
Last modified on
2018 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016681

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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