UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan-Dialysis Outcomes and Practice Patterns Study, 2015-2018(J-DOPPS6)
Title of the study (Brief title)	Japan-Dialysis Outcomes and Practice Patterns Study 6 (J-DOPPS6)
Region	Japan

Condition
Condition	End Stage Renal Disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

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	Tadao Akizawa
Organization	Koshikawa kinen yokohama jin Clinic
Division name	-
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	Kazuhiro Aoyama
Organization	Kyowa Hakko Kirin Co., Ltd.
Division name	Medical Affairs
Address	1-9-2 Otemachi, Chiyoda-ku, Tokyo
TEL	03-5205-7200
Homepage URL
Email	jdopps.info@kyowa-kirin.co.jp

Sponsor
Institute	Arbor Research Collaborative for Health
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	Kyowa Hakko Kirin Co., Ltd.
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	2016 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024141