UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006806 |
|---|---|
| Receipt number | R000008056 |
| Scientific Title | Study of factors associated with fatty acid in the blood of hemodialysis patients :cross-sectional study and cross-over study with EPA ethyl ester. |
| Date of disclosure of the study information | 2011/11/30 |
| Last modified on | 2011/11/30 20:24:20 |
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Basic information
Public title
Study of factors associated with fatty acid in the blood of hemodialysis patients :cross-sectional study and cross-over study with EPA ethyl ester.
Acronym
Study of factors associated with fatty acid in the blood of hemodialysis patients
Scientific Title
Study of factors associated with fatty acid in the blood of hemodialysis patients :cross-sectional study and cross-over study with EPA ethyl ester.
Scientific Title:Acronym
Study of factors associated with fatty acid in the blood of 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 ratio of EPA/AA in blood of chronic dialysis patients. To study the relevance between EPA/AA ratio and traditional CVD risk factors. Also to evaluate the efficacy of EPA ethyl ester for adaptive cases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
1. EPA/AA ratio
2. hs-CRP in blood
3. back ground of patients, risk factors of CVD
Key secondary outcomes
1. ADMA in blood
2. AGEs in blood
3. ABI, IMT
Base
Study type
Interventional
Study design
Basic design
Cross-over
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 ethyl ester (+) to EPA ethyl ester (-)
Interventions/Control_2
EPA ethyl ester (-) to EPA ethyl ester (+)
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 ethyl ester
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
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shouichi Fujimoto |
Organization
University of Miyazaki hospital
Division name
Dialysis Division
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
Zip code
Address
2-9-20 Tsurumachi, Hyuga, Miyazaki
TEL
0982-52-7111
Homepage URL
Sponsor or person
Institute
Dialysis Division, University of Miyazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Dialysis Division, University of Miyazaki Hospital
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
| 2011 | Year | 11 | Month | 30 | 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
| 2011 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | 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
| 2011 | Year | 11 | Month | 30 | Day |
Last modified on
| 2011 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008056
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
