UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039020 |
|---|---|
| Receipt number | R000044489 |
| Scientific Title | Development of screening method for detecting and preventing advanced kidney diseases |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2021/06/28 10:25:57 |
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Basic information
Public title
Development of screening method for detecting and preventing advanced kidney diseases
Acronym
K-SCREAM
Scientific Title
Development of screening method for detecting and preventing advanced kidney diseases
Scientific Title:Acronym
K-SCREAM
Region
| Japan |
Condition
Condition
advanced kidney disease
Classification by specialty
| Nephrology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establish an accurate method for detecting advanced kidney disease from subject with serum creatinine measurements and/or urinalyses in undeserved medical area.
Basic objectives2
Others
Basic objectives -Others
Comparing accuracy for detecting kidney disease between systemic searching by utilizing medical records and practical consultation to nephrologists.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kidney disease determined by elevated serum creatinine and positive proteinuria
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
| 1 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects with serum creatinine measurements and/or urinalyses in our institute
Key exclusion criteria
Subjects with intention of opt-out
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Nagai |
Organization
Kamisu Saiseikai Hospital
Division name
Nephrology, Internal medicine
Zip code
314-0112
Address
7-2-45 Shitte Chuo, Kamisu city, Ibaraki
TEL
0299-97-2111
knagai@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Nagai |
Organization
Kamisu Saiseikai Hospital
Division name
Nephrology, Internal medicine
Zip code
314-0112
Address
7-2-45 Shitte Chuo, Kamisu city, Ibaraki
TEL
0299-97-2111
Homepage URL
knagai@md.tsukuba.ac.jp
Sponsor or person
Institute
Saiseikai
Institute
Department
Personal name
Funding Source
Organization
Undetermined
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
Kamisu Saiseikai
Address
7-2-45 Shitte Chuo, Kamisu city, Ibaraki
Tel
0299-97-2111
knagai@md.tsukuba.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 | 01 | Month | 06 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/jgf2.375
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/jgf2.375
Number of participants that the trial has enrolled
20000
Results
https://onlinelibrary.wiley.com/doi/10.1002/jgf2.375
Results date posted
| 2021 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://onlinelibrary.wiley.com/doi/10.1002/jgf2.375
Participant flow
https://onlinelibrary.wiley.com/doi/10.1002/jgf2.375
Adverse events
https://onlinelibrary.wiley.com/doi/10.1002/jgf2.375
Outcome measures
https://onlinelibrary.wiley.com/doi/10.1002/jgf2.375
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No applicable
Management information
Registered date
| 2019 | Year | 12 | Month | 27 | Day |
Last modified on
| 2021 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044489
| 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 |
