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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033029
Receipt No. R000037654
Scientific Title Clinical utility of urinary gravity / osmolality ratio as an alternate of selectivity index in CKD with proteinuria
Date of disclosure of the study information 2018/06/18
Last modified on 2019/06/18

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Basic information
Public title Clinical utility of urinary gravity / osmolality ratio as an alternate of selectivity index in CKD with proteinuria
Acronym Urinary gravity/osmolality ration in CKD patients
Scientific Title Clinical utility of urinary gravity / osmolality ratio as an alternate of selectivity index in CKD with proteinuria
Scientific Title:Acronym Urinary gravity/osmolality ration in CKD patients
Region
Japan

Condition
Condition chronic kidney disease (CKD) with proteinuria
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical significance of urinary gravity/osmolality ratio as an alternate of selectivity index in differential diagnosis of CKD with proteinuria
Basic objectives2 Others
Basic objectives -Others To evaluate clinical significance of urinary gravity/osmolality ratio as a prognostic marker of CKD with proteinuria
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sensitivity, specificity, and ROC curve of urinary gravity/osmolality ratio in comparison with selectivity index of urinary protein
Key secondary outcomes trajectory patterns of urinary gravity/osmolality ratio in clinical course of CKD with proteinuria, especially nephrotic syndrome

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
110 years-old >=
Gender Male and Female
Key inclusion criteria CKD patients with proteinuria
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yoshitaka
Middle name
Last name Maeda
Organization JA Toride Medical Center
Division name Nephrology
Zip code 271-0068
Address 2-1-1 Hongo, Toride, Ibaraki, Japan
TEL 81-297-74-5551
Email yoshimaeda43@toride-medical.or.jp

Public contact
Name of contact person
1st name Yoshitaka
Middle name
Last name Maeda
Organization JA Toride Medical Center
Division name Nephrology
Zip code 271-0068JA
Address 2-1-1 Hongo, Toride, Ibaraki, Japan
TEL 81-297-74-5551
Homepage URL
Email yoshimaeda43@toride-medical.or.jp

Sponsor
Institute Nephrology division, JA Toride Medical Center
Institute
Department

Funding Source
Organization Nephrology division, JA Toride Medical Center
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 JA Toride Medical Center
Address 2-1-1 Hongo, Toride, Ibaraki, Japan
Tel 81297745551
Email yoshimaeda43@toride-medical.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 JAとりで総合医療センター(茨城県)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 18 Day

Related information
URL releasing protocol http://www.toride-medical.or.jp/
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
2017 Year 12 Month 26 Day
Date of IRB
2018 Year 02 Month 16 Day
Anticipated trial start date
2018 Year 03 Month 01 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
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 06 Month 30 Day

Other
Other related information The concise protocol is opened in the HomePage of JA Toride Medical Center

Management information
Registered date
2018 Year 06 Month 17 Day
Last modified on
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037654

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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