UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013149 |
|---|---|
| Receipt number | R000015323 |
| Scientific Title | Elucidation of the effect of Omega-3-Acid ethyl esters for CKD patients with dyslipidemia, compared to ethyl icosapentate |
| Date of disclosure of the study information | 2014/02/13 |
| Last modified on | 2018/08/18 09:03:19 |
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Basic information
Public title
Elucidation of the effect of Omega-3-Acid ethyl esters for CKD patients with dyslipidemia, compared to ethyl icosapentate
Acronym
Elucidation of the effect of Omega-3-Acid ethyl esters for CKD patients with
Scientific Title
Elucidation of the effect of Omega-3-Acid ethyl esters for CKD patients with dyslipidemia, compared to ethyl icosapentate
Scientific Title:Acronym
Elucidation of the effect of Omega-3-Acid ethyl esters for CKD patients with
Region
| Japan |
Condition
Condition
CKD patients with dyslipidemia
Classification by specialty
| Medicine in general | Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effect of omega 3 fatty acids, compared to ethyl icosapentate for renal function in CKD patients with dyslipidemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(F) LDL, HDL, (F) LDL / HDL ratio, total cholesterol, triglyceride, proteinuria (urinary albumin), sCr, eGFR, urinary L-FABP at 0, 3, and 6 months after starting of treatment
Key secondary outcomes
QOL questionnaire, Quadrant blood fatty acid (EPA / AA ratio, DHA / AA ratio), Oxidized LDL, high-sensitivity CRP, urinary 8-OHDG, ADMA
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
switch to omega 3 fatty acids
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) chronic kidney disease patients with dyslipidemia
2) patients under the medical treatment with Epadel
3) patient who is competent to understand the aim of this study and agree on it
Key exclusion criteria
1) Patients who are bleeding
2) Past medical history of hypersensitivity to Lotriga
3) Judged as ineligible by physicians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Tomino |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Nephrology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1065
yasu@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Suzuki |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Nephrology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1065
Homepage URL
shitoshi@juntendo.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Division of Nephrology, 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
The clinic of Meguro Orthopaedics Surgery and Internal Medicine
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
| 2014 | Year | 02 | Month | 13 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 13 | Day |
Last modified on
| 2018 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015323
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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