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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008619
Receipt No. 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

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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
Email 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
Email shitoshi@juntendo.ac.jp

Sponsor
Institute Department of Internal Medicine, Division of Nephrology, Juntendo University Faculty of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010131

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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