UMIN-CTR Clinical Trial

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
Email	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
Email	knagai@md.tsukuba.ac.jp

Sponsor
Institute	Saiseikai
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044489