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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035027
Receipt No. R000039931
Official scientific title of the study Association between lifestyles and renal replacement therapy in patients with CKD
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/27

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Basic information
Official scientific title of the study Association between lifestyles and renal replacement therapy in patients with CKD
Title of the study (Brief title) Lifestyles and renal replacement therapy
Region
Japan

Condition
Condition Chronic Kidney Disease (CKD)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine associations between lifestyles and initiation of renal replacement therapy in Japanese patients with CKD by using claims database and Specific Health Checkups database from employment-based health insurances.
Basic objectives2 Others
Basic objectives -Others Relative risks of initiation of renal replacement therapy in group with lifestyle compared to group without.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Initiation of renal replacement therapy (dialysis or kidney transplant).
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
40 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria 1).Insureds and their dependents enrolled in both claims and Specific Health Checkups databases.
2). Those who are at age of 40 to 74 as of March 31 at each fiscal year taken Specific Health Checkups.
3). Those who fulfilled criteria of CKD.
Key exclusion criteria Those who underwent renal replacement therapy before starting follow-up.
Target sample size 200000

Research contact person
Name of lead principal investigator Hisashi Urushihara
Organization Faculty of Pharmacy, Keio University
Division name Division of Drug Development and Regulatory Science
Address 1-5-30 Shibakouen, Minato-ku, Tokyo 105-8512, Japan
TEL 03-5400-2649
Email urushihara.hisashi@keio.jp

Public contact
Name of contact person Hisashi Urushihara
Organization Faculty of Pharmacy, Keio University
Division name Division of Drug Development and Regulatory Science
Address 1-5-30 Shibakouen, Minato-ku, Tokyo 105-8512, Japan
TEL 03-5400-2649
Homepage URL
Email urushihara.hisashi@keio.jp

Sponsor
Institute Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tohoku Medical Megabank Organization, Tohoku University
Name of secondary funder(s)

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
2018 Year 12 Month 01 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 08 Month 31 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Study design: Retrospective cohort study using claims database and Specific Health Checkups database run by Japan Medical Data Center.

These databases have accumulated claims data since January 2005 and Specific Health Checkups data since April 2008, respectively from several employment-based health insurances. Those who enrolled in these databases are approximately a million as of March 2016.

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2018 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039931

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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