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 |
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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
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
| 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
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
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
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 |
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
