UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019774
Receipt No. 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 2020/05/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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/
Email k-yamaga@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba, Faculty of Medicine
Institute
Department

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
Email 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
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 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
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022550

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.