UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015853
Receipt number R000018448
Scientific Title Study of the Influenza vaccine immune response using PMMA dialyzer.
Date of disclosure of the study information 2014/12/04
Last modified on 2015/09/28 09:29:03

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Basic information

Public title

Study of the Influenza vaccine immune response using PMMA dialyzer.

Acronym

Influenza vaccine effectiveness in using PMMA dialyzer

Scientific Title

Study of the Influenza vaccine immune response using PMMA dialyzer.

Scientific Title:Acronym

Influenza vaccine effectiveness in using PMMA dialyzer

Region

Japan


Condition

Condition

End-stage renal disease requiring hemodialysis

Classification by specialty

Medicine in general Endocrinology and Metabolism Nephrology
Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Acquisition influenza immunization

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

PMMA dialyzer is related to the immune responsiveness up.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Dialyzers will be changed to the PMMA dialyzer, on patients who was not made immunity to influenza vaccination.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients whose age is over 20 years at the time of enrollment in this study.

Key exclusion criteria

A patient who is judged as the inadequate subject of this study by the doctor.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iehisa Matsuyama

Organization

Oita naika clinic

Division name

Zip code


Address

Kentoku-machi,3-1-5, Oita-city, Oita,Japan

TEL

097-535-1569

Email

kaede-m-06@oita-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaede Ishida

Organization

Oita university hospital

Division name

Nephrology

Zip code


Address

Idai-gaoka,1-1, Hasama-machi, Yufu-city, Oita,Japan

TEL

09074541583

Homepage URL


Email

kaede-m-06@oita-u.ac.jp


Sponsor or person

Institute

Oita naika clinic

Institute

Department

Personal name



Funding Source

Organization

Toray Industories Inc.

Organization

Division

Category of Funding Organization

Profit organization

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

2014 Year 12 Month 04 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

2014 Year 12 Month 04 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 04 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

2014 Year 12 Month 04 Day

Last modified on

2015 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018448


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name