UMIN-CTR Clinical Trial

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
Email	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
Email	c.masaki@khg.or.jp

Sponsor
Institute	Kawashima Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046881