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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012150
Receipt No. R000014204
Official scientific title of the study Trial for the initiation of dialysis patients by EPA for prevention of cardiovascular event in Juntendo University Hospital
Date of disclosure of the study information 2013/10/31
Last modified on 2016/01/14

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Basic information
Official scientific title of the study Trial for the initiation of dialysis patients by EPA for prevention of cardiovascular event in Juntendo University Hospital
Title of the study (Brief title) J-TRIDENT
Region
Japan

Condition
Condition initiation of dialysis patient
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 prevention of cardiovascular event
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cardiovascular event
Key secondary outcomes vascular access trouble

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 administration of EPA, with diabetes mellitus(DM)
Interventions/Control_2 not administration of EPA, with diabetes mellitus(DM)
Interventions/Control_3 administration of EPA, without diabetes mellitus(DM)
Interventions/Control_4 not administration of EPA, without diabetes mellitus(DM)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria initiation of dialysis patient
Key exclusion criteria patient with known bleeding disorders
Target sample size 200

Research contact person
Name of lead principal investigator Yasuhiko Tomino
Organization Department of Internal Medicine,Juntendo University Faculty of Medicine
Division name Nephrology
Address 3-1-3Bunkyou-ku, Hongou,Tokyo
TEL 03-5802-1065
Email yasu@juntendo.ac.jp

Public contact
Name of contact person Hiroaki Io
Organization Department of Internal Medicine,Juntendo University Faculty of Medicine
Division name Nephrology
Address 3-1-3Bunkyou-ku, Hongou,Tokyo
TEL 03-3813-3111
Homepage URL
Email chiken@juntendo.ac.jp

Sponsor
Institute Department of Internal Medicine,Juntendo University Faculty of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 10 Month 31 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 10 Month 18 Day
Anticipated trial start date
2013 Year 10 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2013 Year 10 Month 28 Day
Last modified on
2016 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014204


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