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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040723
Receipt No. R000046489
Scientific Title An observational study comparing renal injury and renal elasticity evaluated by ultrasound elastography
Date of disclosure of the study information 2020/06/11
Last modified on 2020/06/11

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Basic information
Public title Comparison of renal injury and renal elasticity evaluated by ultrasonic elastography
Acronym Comparison of renal injury and renal elasticity evaluated by ultrasonic elastography
Scientific Title An observational study comparing renal injury and renal elasticity evaluated by ultrasound elastography
Scientific Title:Acronym An observational study comparing renal injury and renal elasticity evaluated by ultrasound elastography
Region
Japan

Condition
Condition Chronic kidney injury
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to analyze correlation between renal elasticity measured by ultrasound elastography, renal function, urine findings, conventional echography findings, pathological findings.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The diagnostic accuracy will be examined by comparing the elastic modulus obtained by ultrasound elastography with the results of renal biopsy.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Subjects who can be done the measurement by abdominal ultrasound.
2) Written agreement of participation for this study could be obtained.
3) Patients who could be received the histological evaluation by laparoscopic renal biopsy.
Key exclusion criteria 1) Written agreement of participation for this study could not be obtained.
2) Subjects who cannot be done the measurement by abdominal ultrasound.
3) The subjects who were estimated that it is inappropriate to participate the study by the responsible physician.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Osamu
Middle name
Last name Yamaguchi
Organization Ehime University Graduate School of Medicine
Division name Department of Cardiology, Pulmonology, Hypertension and Nephrology
Zip code 791-0295
Address Shitsukawa, Toon, Ehime 791-0295, Japan
TEL +81-89-960-5303
Email makita.ayu.ik@ehime-u.ac.jp

Public contact
Name of contact person
1st name Ayu
Middle name
Last name Makita
Organization Ehime University Graduate School of Medicine
Division name Department of Cardiology, Pulmonology, Hypertension and Nephrology
Zip code 791-0295
Address Shitsukawa, Toon, Ehime 791-0295, Japan
TEL +81-89-960-5303
Homepage URL
Email makita.ayu.ik@ehime-u.ac.jp

Sponsor
Institute Department of Cardiology, Pulmonology, Hypertension and Nephrology, Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiology, Pulmonology, Hypertension and Nephrology, Ehime University Graduate School of Medicine
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 Research Cooperation Division of Ehime University School of Medicine
Address 454 Shitsukawa, Toon, Ehime 791-0295, Japan
Tel +81-89-960-5172
Email rinri@m.ehime-u.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
2020 Year 06 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
2019 Year 06 Month 24 Day
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The patients who participate in this study will be received blood biochemical examination, urinalysis, conventional echography and renal histological evaluation before the examination of ultrasound elastography. We analyze those data, and evaluate the accuracy of the diagnosis for renal elasticity by ultrasound elastography to other procedures.

Management information
Registered date
2020 Year 06 Month 11 Day
Last modified on
2020 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046489

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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