UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041144 |
|---|---|
| Receipt number | R000046881 |
| Scientific Title | Investigation of the usefulness of shear wave elastography (SWE) in renal disease |
| Date of disclosure of the study information | 2020/08/11 |
| Last modified on | 2020/07/17 21:23:27 |
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Basic information
Public title
Investigation of the usefulness of shear wave elastography (SWE) in renal disease
Acronym
Investigation of the usefulness of shear wave elastography (SWE) in renal disease
Scientific Title
Investigation of the usefulness of shear wave elastography (SWE) in renal disease
Scientific Title:Acronym
Investigation of the usefulness of shear wave elastography (SWE) in renal disease
Region
| Japan |
Condition
Condition
renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investgate the usefulness of SWE in renal disease and factors affecting SWE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
shear wave velocity and elastic modulus performed prior to renal biopsy
Key secondary outcomes
renal biopsy tissue score (glamellar cell progression, segmental bombage, global sclaimis, internal infrastructure cell infrabation, internal fiscal, rent tubular attropy, vessel walling, hellod deaths, hellod degenerate oftarities), urine osmotic pressure, ultrasound findings (renal size, marginal properties, corruginal contrast, real luminance, RI, PSV, depth), diagnosis with renal biopsy, CKD stage, Cr, BUN, eGFR, 24-hour creatine clearance, UA, Ca, Hb, Ht, Glu, HbA1c, T-Cho, LDL-C, HDL-C, TG, beta2-MG, urine beta2-MG, urine NAG, urine protein/Cr ratio, urine protein, urinary occult blood, BMI, blood pressure, FMD (Flow Mediated Dilation)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients undergoing renal biopsy in our hospital and healthy volunteers (according to the severity classification of chronic kidney disease; G1A1, G2A1)
Key exclusion criteria
patients who do not agree to participate in this study and patients who are considered unsuitable for research
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Masaki |
Organization
Kawashima Hospital
Division name
Department of Laboratory
Zip code
770-0011
Address
1-39 Kitasakoichiban-cho, Tokushima
TEL
088-631-0100
c.masaki@khg.or.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Masaki |
Organization
Kawashima Hospital
Division name
Department of Laboratory
Zip code
770-0011
Address
1-39 Kitasakoichiban-cho, Tokushima
TEL
088-631-0100
Homepage URL
c.masaki@khg.or.jp
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Kawashima Hospital
Address
1-39 Kitasakoichiban-cho, Tokushima
Tel
088-631-0100
c.masaki@khg.or.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 | 08 | 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
140
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ultrasonography is performed prior to renal biopsy for patients who perform renal biopsy in our hospital. We examine the relationship between SWE and renal fibrosis, and the factors affecting SWE. Renal fibrosis area is calculated using image J software (National Institutes of Health). Labo data prior to approval by the Research Ethics Review Committee is also used and evaluated. In addition, as comparison targets, we perform kidney ultrasonography in healthy volunteers (severity classification of chronic kidney disease; G1A1, G2A1).
Management information
Registered date
| 2020 | Year | 07 | Month | 17 | Day |
Last modified on
| 2020 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046881
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
