UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017853
Receipt number R000020682
Scientific Title Efficacy of n-3 polyunsaturated fatty acids in hemodialysis patients with dyslipidemia
Date of disclosure of the study information 2015/06/10
Last modified on 2015/06/10 01:58:12

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Basic information

Public title

Efficacy of n-3 polyunsaturated fatty acids in hemodialysis patients with dyslipidemia

Acronym

Efficacy of n-3 polyunsaturated fatty acids in hemodialysis patients with dyslipidemia

Scientific Title

Efficacy of n-3 polyunsaturated fatty acids in hemodialysis patients with dyslipidemia

Scientific Title:Acronym

Efficacy of n-3 polyunsaturated fatty acids in hemodialysis patients with dyslipidemia

Region

Japan


Condition

Condition

chronic kidney disease, dyslipidemia

Classification by specialty

Medicine in general Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of usefulness and safety of n-3 polyunsaturated fatty acids

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

evaluation of changes in atherosclerosis indexes, blood pressure variability

Key secondary outcomes

changes in coagulation, inflammation-related index and dialysis-related index


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

4g of omega-3 fatty acid ethyl granular capsule for 3 months

Interventions/Control_2

no administration of omega-3 fatty acid ethyl granular capsule for 3 months, then 2g administration of omega-3 fatty acid ethyl granular capsule for 3 months (if patient wish to do)

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

1. Age of 20 years old or older
2. Patients without administration of n-3 polyunsaturated fatty acids (including supplements) at least for 6 months
3. Patients who have voluntarily provided written informed consent after fully understanding the information given about participation in the study.

Key exclusion criteria

1. History of allergy to n-3 polyunsaturated fatty acids
2. Pregnant women or women suspected of being pregnant
3. Patients who have active bleeding
4. Judged by investigator not to be appropriate for inclusion in this study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yusuke Kobayashi

Organization

Yokosuka city hospital

Division name

Division of nephrology

Zip code


Address

1-3-2, Nagasaka, Yokosuka

TEL

046-856-3136

Email

yusuke.kob@live.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yusuke Kobayashi

Organization

Yokosuka city hospital

Division name

Division of nephrology

Zip code


Address

1-3-2, Nagasaka, Yokosuka

TEL

046-856-3136

Homepage URL


Email

yusuke.kob@live.jp


Sponsor or person

Institute

Yokosuka city hostotai

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


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



Other administrative information

Date of disclosure of the study information

2015 Year 06 Month 10 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

Open public recruiting

Date of protocol fixation

2015 Year 06 Month 05 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 10 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

2015 Year 06 Month 10 Day

Last modified on

2015 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020682


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name