UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010243 |
|---|---|
| Receipt number | R000011991 |
| Scientific Title | Evaluation of elasticity of the kidneys by Acoustic Ratiation Force Impulse (ARFI) in CKD patients |
| Date of disclosure of the study information | 2013/03/16 |
| Last modified on | 2013/09/23 16:47:26 |
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Basic information
Public title
Evaluation of elasticity of the kidneys by Acoustic Ratiation Force Impulse (ARFI) in CKD patients
Acronym
ARFI-elastometry of the kidneys in CKD patients
Scientific Title
Evaluation of elasticity of the kidneys by Acoustic Ratiation Force Impulse (ARFI) in CKD patients
Scientific Title:Acronym
ARFI-elastometry of the kidneys in CKD patients
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure shear wave velocity (SWV) of the kidneys by acoustic radiation force impulse and to identify the main affecting factor of SWV in chronic kidney disease CKD).
Basic objectives2
Others
Basic objectives -Others
To evaluate relationship between kidney function and the kidney tissue elasticity which was measured by ARFI
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of the factor which affects kidney tissue elasticity measured by ARFI
Key secondary outcomes
none
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Evaluation of tissue elasticity by ARFI
Interventions/Control_2
Measurement of renal blood flow by Doppler measurement
Interventions/Control_3
Estimation of the degree of athrosclerosis of large vessels by ba PWV
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease
Key exclusion criteria
patients with one functioning kidney,
patients with multiple cysts of the kidneys
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichiro Asano |
Organization
Kurashiki Central Hospital
Division name
Nephrology
Zip code
Address
1-1-1 Miwa Kurashiki-city, Okayama
TEL
+81-86-422-0210
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Asano |
Organization
Kurashiki Central Hospital
Division name
Nephrology
Zip code
Address
1-1-1 Miwa Kurashiki-city
TEL
+81-86-422-0210
Homepage URL
ka11734@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Kurashiki Central Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2013 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2013 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 06 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 06 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 14 | Day |
Last modified on
| 2013 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011991
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