UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000020938
Receipt number	R000024141
Scientific Title	Japan-Dialysis Outcomes and Practice Patterns Study, 2015-2018(J-DOPPS6)
Date of disclosure of the study information	2016/02/09
Last modified on	2019/02/13 08:20:10

* 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

Japan-Dialysis Outcomes and Practice Patterns Study,
2015-2018(J-DOPPS6)

Acronym

Japan-Dialysis Outcomes and Practice Patterns Study 6 (J-DOPPS6)

Scientific Title

Japan-Dialysis Outcomes and Practice Patterns Study,
2015-2018(J-DOPPS6)

Scientific Title:Acronym

Japan-Dialysis Outcomes and Practice Patterns Study 6 (J-DOPPS6)

Region

Japan

Condition

End Stage Renal Disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

J-DOPPS is a part of the Worldwide-DOPPS (DOPPS), an international collaborative research.
The purpose of DOPPS is to investigate and compare the hemodialysis treatment around the world, and to examine the factors that influence the outcome, such as survival rate and quality of life of hemodialysis patients.
It is to collect the data of actual condition of hemodialysis treatent in Japan and to provide them to DOPPS research preside; the purpose of DOPPS is achieved by the cooperation of several countries in the world.

Basic objectives2

Others

Basic objectives -Others

Survey of hemodialysis treatment

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Survey of hemodialysis treatment
(Mortality,Hospitalization, Vascular access,QOL)

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

18 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

18 years of age or older and receiving chronic in-center hemodialysis for the treatment of chronic kidney failure.

Key exclusion criteria

1.Patients who receive other bloof purification treatment than hemodialysis
2.Patients who receive in-home dialysis
3.Patients who receive hemodialysis for acute renal failure

Target sample size

2300

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Tadao Akizawa

Organization

Koshikawa kinen yokohama jin Clinic

Division name

Zip code

Address

36-3 Chigasaki-thuo Tuzuki-ku Yokohama-shi, Kanagawa

TEL

03-6408-6805

Email

jdopps.info@kyowa-kirin.co.jp

Public contact

Name of contact person

1st name

Middle name

Last name Kazuhiro Aoyama

Organization

Kyowa Hakko Kirin Co., Ltd.

Division name

Medical Affairs

Zip code

Address

1-9-2 Otemachi, Chiyoda-ku, Tokyo

TEL

03-5205-7200

Homepage URL

Email

jdopps.info@kyowa-kirin.co.jp

Sponsor or person

Institute

Arbor Research Collaborative for Health

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

Kyowa Hakko Kirin Co., Ltd.

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 09 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

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

Completed

Date of protocol fixation

2015 Year 04 Month 10 Day

Date of IRB

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

Date of closure to data entry

2018 Year 09 Month 30 Day

Date trial data considered complete

Date analysis concluded

Other

Other related information

1.Design:Multicenter prospective observational study
2.Study sites:Hemodialysis acilities are randomly selected from the list of JSDT that are treating at least 24 HD patients,facilities are stratified by geographic region and unit type.
3.Study participants:Between 20 to 40 participants,in order to be eligible for inclusion criteria and not conflict with the exclusion criteria,participants are randomly selected from the list of all HD patients at the facility,and the study is conducted after the patient's or proxy's consent is acquired.
4.Target number of participants: about 2,300
5.Recruitment period: patients enrolled at the participating facilities from June 1, 2015 to September 30, 2018
6.Survey item
CENSUS
Medical Questionnaire(MQ)
Patient Questionnaire(PQ)
Interval Summary(IS)
Medical Director Survey(MDS)
Termination Form(TF)

Management information

Registered date

2016 Year 02 Month 08 Day

Last modified on

2019 Year 02 Month 13 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024141

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name