UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040937 |
|---|---|
| Receipt number | 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 14:50:10 |
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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
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
ckd_dokenpo@prism.hs.med.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Fukuma Reseach Group
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
