UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019774 |
|---|---|
| Receipt number | R000022550 |
| Scientific Title | Surveillance of chronic kidney diseases based on Kokuho-database (KDB) in Japan |
| Date of disclosure of the study information | 2015/11/13 |
| Last modified on | 2023/05/20 10:29:27 |
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Basic information
Public title
Surveillance of chronic kidney diseases based on Kokuho-database (KDB) in Japan
Acronym
CKD Surveillance based on KDB
Scientific Title
Surveillance of chronic kidney diseases based on Kokuho-database (KDB) in Japan
Scientific Title:Acronym
CKD Surveillance based on KDB
Region
| Japan |
Condition
Condition
Chronic kidney diseases
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the evidence for avoiding development of chronic kidney disease (CKD) and progression to end-stage renal disease by observation in patients with CKD stage 3 or more.
Basic objectives2
Others
Basic objectives -Others
Prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-causes mortality, cardiovascular mortality, starting renal replacement therapy (i.e. hemodialysis, peritoneal dialysis or renal transplantation), and loss of residual renal function (30% increment in serum creatinine and/or 30% decline in estimated glomerular filtration rate)
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons receiving national insurance (Kokuho) and with diseases covered by the medical insurance.
Key exclusion criteria
Persons not willing to participate in this research
Target sample size
35000000
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yamagata |
Organization
University of Tsukuba, Faculty of Medicine
Division name
Division of Clinical Medicine, Department of Nephrology
Zip code
311-8575
Address
1-1-1, Ten-nodai, Tsukuba. Ibaraki, Japan
TEL
029-853-3202
k-yamaga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yamagata |
Organization
University of Tsukuba, Faculty of Medicine
Division name
Division of Clinical Medicine, Department of Nephrology
Zip code
311-8575
Address
1-1-1, Ten-nodai, Tsukuba. Ibaraki, Japan
TEL
029-853-3202
Homepage URL
http://reach-j.jp/
k-yamaga@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
029-853-6309
Tel
029-853-6309
sien.ningenss@un.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
| 2015 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
https://nephtsukuba.wixsite.com/nephrology-tsukuba/kdb-ckd
Publication of results
Partially published
Result
URL related to results and publications
http://reach-j.jp/wg/wg2
Number of participants that the trial has enrolled
2849557
Results
The estimated prevalence of reduced eGFR and/or proteinuria in the baseline year alone was 15.7% in men and 13.6% in women; the prevalence of definitive CKD was 10.9% in men and 9.2% in women. The number of CKD cases based on a single-year test in Japanese adults over 20 years of age increased from 13.3 million to 14.8 million between 2005 and 2015.
Results date posted
| 2023 | Year | 05 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Using a population-based cohort that underwent annual specific health checkups in Japan in 2014 and 2015.
Participant flow
Though the aim was to collect subjects evenly from all of Japan, there was nevertheless some regional bias in subject numbers and the implementation rates of urinalysis and serum creatinine measurement. Of 2849557 persons aged 40-74 years who were subject to health checkups in 301 municipalities of 28 prefectures, 1059888 were examined at baseline, and 763104 (320901 men and 442203 women) had data for eGFR and proteinuria in both 2014 and in 2015.
Adverse events
Not applicable
Outcome measures
CKD prevalence
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Retrospective cohort study
From 2015 Sept. to 2019 Mar.
Subject: Participants having specific medical checkups.
Collecting items: data from the specific medical checkups, health guidance and medical prescription of the subject.
Management information
Registered date
| 2015 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022550
| Research Plan | |
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| 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 |
