UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008381 |
|---|---|
| Receipt number | 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 07:39:02 |
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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
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
hina2008@fc.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine, University of Miyazaki
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009854
