UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014329 |
|---|---|
| Receipt number | 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 11:09:10 |
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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
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
ayu8823@mx31.tiki.ne.jp
Sponsor or person
Institute
Department of Medicine and Clinical
Science, Okayama University Graduate
School of Medicine, Dentistry and
Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016681
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
