UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040723 |
|---|---|
| Receipt number | 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 | 2024/02/20 14:49:51 |
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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
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
makita.ayu.ik@ehime-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Pulmonology, Hypertension and Nephrology, Ehime University Graduate School of Medicine
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10157-021-02063-2
Number of participants that the trial has enrolled
29
Results
The mean renal elasticity of mild, moderate, and severe renal fibrosis was 3.40, 3.98, and 4.77, respectively. Renal elasticity of native kidneys was significantly positively correlated with the grade of renal fibrosis (P = 0.003). At the cutoff point of 3.81, the area under the curve, sensitivity, and specificity were 0.778, 68.4%, and 81.8%, respectively.
Results date posted
| 2022 | Year | 06 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 05 | Month | 08 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046489
| Research Plan | |
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| Registered date | File name |
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