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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008381
Receipt No. R000009854
Scientific Title Effect of EPA on cardiovascular event in maintenance hemodialysis patients :a prospective, comparative study.
Date of disclosure of the study information 2012/07/09
Last modified on 2012/07/09

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Basic information
Public title Effect of EPA on cardiovascular event in maintenance hemodialysis patients :a prospective, comparative study.
Acronym Effect of EPA on hemodialysis patients
Scientific Title Effect of EPA on cardiovascular event in maintenance hemodialysis patients :a prospective, comparative study.
Scientific Title:Acronym Effect of EPA on hemodialysis patients
Region
Japan

Condition
Condition Maintenance hemodialysis patients
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effct of EPA on cardiovascular events in chronic dialysis patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1. Occurrence of cardiovascular events
2. EPA/AA ratio
3. hs-CRP levels
Key secondary outcomes 1. Serum ADMA levels
2. Serum AGEs levels
3. ABI, IMT

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 EPA(+)
Interventions/Control_2 EPA(-)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Maintenance hemodialysis patients
Key exclusion criteria 1) Pts who meet the contraindiation criteria in package insert of EPA
2) Pregnant or possibly pregnant pts, pts on lactation
3) Inappropriate pts for this study according to the investigator's judgment
4) The patients who do not agree with this study
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shouichi Fujimoto
Organization Faculty of Medicine, University of Miyazaki
Division name Department of Hemovascular Medicine and Artificial Organs
Zip code
Address 5200, Kihara, Kiyotake, Miyazaki
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Inagaki
Organization Chiyoda Hospital
Division name Internal Medicine (Dialysis Unit)
Zip code
Address 88 Furutamachi, Hidiya, Hyuga, Miyazaki
TEL 0982-52-7111
Homepage URL
Email hina2008@fc.miyazaki-u.ac.jp

Sponsor
Institute Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine, University of Miyazaki
Institute
Department

Funding Source
Organization Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine, University of Miyazaki
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Yokota Naika
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 07 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 Enrolling by invitation
Date of protocol fixation
2012 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 09 Day
Last modified on
2012 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009854

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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