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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024810
Receipt No. 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 2019/05/15

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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
Email 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
Email kanozawa@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

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
Email 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
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 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
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027933

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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