UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012150 |
|---|---|
| Receipt number | R000014204 |
| Scientific Title | 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 14:56:57 |
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Basic information
Public title
Trial for the initiation of dialysis patients by EPA for prevention of cardiovascular event in Juntendo University Hospital
Acronym
J-TRIDENT
Scientific Title
Trial for the initiation of dialysis patients by EPA for prevention of cardiovascular event in Juntendo University Hospital
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Tomino |
Organization
Department of Internal Medicine,Juntendo University Faculty of Medicine
Division name
Nephrology
Zip code
Address
3-1-3Bunkyou-ku, Hongou,Tokyo
TEL
03-5802-1065
yasu@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Io |
Organization
Department of Internal Medicine,Juntendo University Faculty of Medicine
Division name
Nephrology
Zip code
Address
3-1-3Bunkyou-ku, Hongou,Tokyo
TEL
03-3813-3111
Homepage URL
chiken@juntendo.ac.jp
Sponsor or person
Institute
Department of Internal Medicine,Juntendo University Faculty of Medicine
Institute
Department
Personal name
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)
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
| 2013 | Year | 10 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 10 | Month | 18 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014204
