UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Chronic Kidney Disease Japan Cohort (CKD-JAC) Study
Title of the study (Brief title)	Chronic Kidney Disease Japan Cohort (CKD-JAC) Study
Region	Japan

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

Objectives
Narrative objectives1	The study aim encompasses the following issues: 1) Common risk factors are associated with both progression of CKD and development of ESRD. 2) Risk factors are associated with development of CVD. 3) The burden of CKD decreases the QOL of patients, and increases hospitalization.
Basic objectives2	Others
Basic objectives -Others	Deterioration of renal function, Cardiovascular disease related events, Death
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcomes are progression of CKD defined by reduction in eGFR, CVD events and all cause mortality
Key secondary outcomes	The secondary outcomes are QOL and hospitalization.

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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1.A broad spectrum of CKD with eGFR of 10-59 mL/min/1.73m2 2.Patients who are not scheduled dialysis initiation. 3.Patients who give a written consent for this study 4.Japanese patients living in Japan
Key exclusion criteria	1.liver cirrhosis 2.HIV/AIDS 3.transplant recipients and patients 4.polycystic kidney disease 5.cancer
Target sample size	3000

Research contact person
Name of lead principal investigator	Akira Hishida
Organization	Yaizu City Hospital
Division name	-
Address	1000,Michihara, Yaizu-city,Shizuoka,Japan
TEL	054-623-3111
Email	akira.hishida@hospital.yaizu.shizuoka.jp

Public contact
Name of contact person	Toru Ushigaki
Organization	Kyowa Hakko Kirin Co., Ltd.
Division name	Medical Affairs
Address	1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan
TEL	03-3282-0242
Homepage URL
Email	ckdjac2@kyowa-kirin.co.jp

Sponsor
Institute	Kyowa Hakko Kirin Co., Ltd.
Institute
Department

Funding Source
Organization	Kyowa Hakko 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)

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 12 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 04 Month 01 Day
Anticipated trial start date	2007 Year 04 Month 01 Day
Last follow-up date	2012 Year 12 Month 31 Day
Date of closure to data entry	2013 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 05 Month 31 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27412450
Results	Refer to the article 1.Primary Endpoint:Renal event https://www.ncbi.nlm.nih.gov/pubmed/27412450 2.Primary Endpoint:CVD https://www.ncbi.nlm.nih.gov/pubmed/27884399
Other related information	The multicenter observational study in Japan 1. Study Design: Cohort study 2. The way for patient's subscription: CKD Patients who visited trial sites from 2007 to 2008 and met the inclusion criteria were registered. 3.Test Items ･ Patients Background ･ Clinical data ･Biological sampling and measurements ･ ESRD, CVD related events ･ Patients Questionnaires ･ 24hr Ambulatory Blood Pressure Monitoring (Sub Cohort) ･ Medical Expenses for Patients with CKD (Sub Cohort)

Management information
Registered date	2015 Year 12 Month 02 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023138