UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008619 |
|---|---|
| Receipt number | R000010131 |
| Scientific Title | Effects of ethyl-icosapentate on renal function in patients with chronic kidney disease |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2015/03/03 22:48:44 |
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Basic information
Public title
Effects of ethyl-icosapentate on renal function in patients with chronic kidney disease
Acronym
Effects of ethyl-icosapentate on renal function in patients with chronic kidney disease
Scientific Title
Effects of ethyl-icosapentate on renal function in patients with chronic kidney disease
Scientific Title:Acronym
Effects of ethyl-icosapentate on renal function in patients with chronic kidney disease
Region
| Japan |
Condition
Condition
Chronic kidney disease with hyperlipidemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of ethyl icosapentate on renal function in chronic kidney disease patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Serum lipid: (F) LDL, HDL,
(F) LDL/HDL ratio, total cholesterol, Triglyceride
Renal function:
proteinuria(albuminurina),
serum Creatinine ,
eGFR(estimated Glomerular Filtration Rate) , serum cystatin C, Urinary Liver-Type Fatty Acid Binding Protein,
Fraction of serum fatty acids(EPA/AA ratio)
Key secondary outcomes
high sensitivity CRP, RLP-C,VLDL
apolipoprotein(A1,B,E),8-OHDG
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
Add-on Ethyl-icosapentate
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. Dyslipidemic patients with chronic kidney disease.
2. Patients who are capable of understanding the informed consent and are agree to join this study.
Key exclusion criteria
1. Patients who are easy to bleed.
2. Patients treated with ethyl icosapentate at the time of study initiation.
3. Patients who are judged as ineligible by clinical physicians.
Target sample size
50
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
shitoshi@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
03-3813-3111
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
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
順天堂大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 06 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | 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
| 2012 | Year | 08 | Month | 04 | Day |
Last modified on
| 2015 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010131
