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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040937
Receipt No. R000046741
Scientific Title Retrospective cohort study on unmet medical needs in chronic kidney disease treatments.
Date of disclosure of the study information 2020/07/01
Last modified on 2020/07/06

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Basic information
Public title Retrospective cohort study on unmet medical needs in chronic kidney disease treatments.
Acronym Retrospective cohort study.
Scientific Title Retrospective cohort study on unmet medical needs in chronic kidney disease treatments.
Scientific Title:Acronym Retrospective cohort study.
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal unmet medical needs on the prognosis of chronic kidney disease (CKD) by understanding the reality of CKD treatments from large-scale health data and identifying the scale and characteristics of patients in need of medical intervention.
Basic objectives2 Others
Basic objectives -Others Analysis combining epidemiological and machine learning models.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Chronological changes in eGFR on CKD patients including those who are undiagnosed, and then identifying patients with an increased risk of eGFR decline.
Key secondary outcomes The reality of CKD treatments and transition in medical expenses according to eGFR decline.

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 Adult and family members of the National Health Insurance Association/Society of Engineering and Construction Contractors.
Key exclusion criteria Patients whose Scr values are extremely high or low.
Target sample size 1400000

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Fukuma
Organization Graduate School of Medicine, Kyoto University
Division name Department of Human Health Science
Zip code 606-8397
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-366-7675
Email fukuma.shingo.3m@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Shingo
Middle name
Last name Fukuma
Organization Graduate School of Medicine, Kyoto University
Division name Department of Human Health Science
Zip code 606-8397
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-366-7675
Homepage URL
Email ckd_dokenpo@prism.hs.med.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Fukuma Reseach Group
Institute
Department

Funding Source
Organization Kyowa Kirin. Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.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 07 Month 01 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 1400000
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
2020 Year 06 Month 24 Day
Date of IRB
2020 Year 06 Month 29 Day
Anticipated trial start date
2020 Year 06 Month 29 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To reveal unmet medical needs on the prognosis of chronic kidney disease (CKD) by understanding the reality of CKD treatments from large-scale health data and identifying the scale and characteristics of patients in need of medical intervention.

Management information
Registered date
2020 Year 06 Month 29 Day
Last modified on
2020 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046741

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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