UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020038
Receipt number R000023138
Scientific Title Chronic Kidney Disease Japan Cohort (CKD-JAC) Study
Date of disclosure of the study information 2015/12/03
Last modified on 2018/04/17 10:32:28

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Basic information

Public title

Chronic Kidney Disease Japan Cohort (CKD-JAC) Study

Acronym

Chronic Kidney Disease Japan Cohort (CKD-JAC) Study

Scientific Title

Chronic Kidney Disease Japan Cohort (CKD-JAC) Study

Scientific Title:Acronym

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

1st name
Middle name
Last name Akira Hishida

Organization

Yaizu City Hospital

Division name

-

Zip code


Address

1000,Michihara, Yaizu-city,Shizuoka,Japan

TEL

054-623-3111

Email

akira.hishida@hospital.yaizu.shizuoka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toru Ushigaki

Organization

Kyowa Hakko Kirin Co., Ltd.

Division name

Medical Affairs

Zip code


Address

1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan

TEL

03-3282-0242

Homepage URL


Email

ckdjac2@kyowa-kirin.co.jp


Sponsor or person

Institute

Kyowa Hakko Kirin Co., Ltd.

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/27412450

Number of participants that the trial has enrolled


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

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

Completed

Date of protocol fixation

2007 Year 04 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023138


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name