UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024810 |
|---|---|
| Receipt number | R000027933 |
| Scientific Title | Clinical evaluation of kidney injury by assessing renal blood flow with ultrasonography |
| Date of disclosure of the study information | 2016/11/11 |
| Last modified on | 2022/12/03 20:03:36 |
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Basic information
Public title
Clinical evaluation of kidney injury by assessing renal blood flow with ultrasonography
Acronym
Clinical evaluation of kidney injury by assessing renal blood flow with ultrasonography
Scientific Title
Clinical evaluation of kidney injury by assessing renal blood flow with ultrasonography
Scientific Title:Acronym
Clinical evaluation of kidney injury by assessing renal blood flow with ultrasonography
Region
| Japan |
Condition
Condition
tublointerstitial nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, the incidence of ischemic tubulo-interstitial nephropathy (TIN) associated with renal vascular disorder is thought to be increased with aging. However, its diagnostic tool is poorly available at present because the urine abnormality of TIN is usually very faint.
Recently, it has been reported that the resistive index (RI) measured by renal vascular doppler ultrasonography (RV-US) might be a potential tool for the renal damage . The resistive index is measurable at various part of artery including main trunk of renal artery (RA) and intra-renal artery (IRA) corresponding to inter-lobular artery, however, it is not revealed which one is more adequate for the assessment of TIN. In addition, threshold of RI should be decided for its clinical application, however, the specific value has not been proposed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relationship of NAG /urine Cr and 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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Clinically cases suspected of renal vascular hypertension (Renovascular Hypertension = RVH), and progressive renal dysfunction lacking urinary abnormality
Key exclusion criteria
Serum Cr equivalent to CKD stage G5 (3.50 mg / dL or more, eGFR less than 10 ml / min)
Maintenance dialysis patient
Cases meeting diagnostic criteria for nephrotic syndrome
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | MINORU |
| Middle name | |
| Last name | HATANO |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Nephrology and Hypertension
Zip code
350-8550
Address
Kamoda 1981, Kawagoe, Saitama 350-8550, Japan
TEL
0492283584
mino910@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | KOUICHI |
| Middle name | |
| Last name | KANOUZAWA |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Nephrology and Hypertension
Zip code
350-8550
Address
Kamoda 1981, Kawagoe, Saitama 350-8550, Japan
TEL
049-228-3584
Homepage URL
kanozawa@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Kamoda Gland
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical Center, Saitama Medical University
Address
Kamoda 1981, Kawagoe, Saitama 350-8550, Japan
Tel
049-228-3584
mino910@saitama-med.ac.jp
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
| 2016 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
no confirm
Publication of results
Unpublished
Result
URL related to results and publications
no confirm
Number of participants that the trial has enrolled
1
Results
no confirm
Results date posted
| 2022 | Year | 12 | Month | 03 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
no confirm
Date of the first journal publication of results
Baseline Characteristics
no confirm
Participant flow
no confirm
Adverse events
no result
Outcome measures
no result
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2016 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2016 | Year | 11 | Month | 11 | Day |
Last modified on
| 2022 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027933
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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