UMIN-CTR Clinical Trial

Basic information
Public title	Association between lifestyles and renal replacement therapy in patients with CKD
Acronym	Lifestyles and renal replacement therapy
Scientific Title	Association between lifestyles and renal replacement therapy in patients with CKD
Scientific Title:Acronym	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	1st name Hisashi Middle name Last name Urushihara
Organization	Faculty of Pharmacy, Keio University
Division name	Division of Drug Development and Regulatory Science
Zip code	1058512
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	1st name Hisashi Middle name Last name Urushihara
Organization	Faculty of Pharmacy, Keio University
Division name	Division of Drug Development and Regulatory Science
Zip code	1058512
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)

IRB Contact (For public release)
Organization	Ethics committee for research involving human subjects, Faculty of Pharmacy, Keio University
Address	1-5-30 Shibakouen, Minato-ku, Tokyo 105-8512, Japan
Tel	03-3434-6241
Email	skc-soumu@adst.keio.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	2018 Year 12 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	149620
Results	Manuscript preparing
Results date posted	2019 Year 09 Month 05 Day
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	2018 Year 08 Month 31 Day
Date of IRB	2018 Year 08 Month 31 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2018 Year 10 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 01 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
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	2019 Year 09 Month 06 Day

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