UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028658
Receipt number R000032804
Scientific Title Examination of the adverse event related to influenza virus vaccines in children with idiopathic nephrotic syndrome
Date of disclosure of the study information 2017/08/14
Last modified on 2018/10/26 20:16:09

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Basic information

Public title

Examination of the adverse event related to influenza virus vaccines in children with idiopathic nephrotic syndrome

Acronym

Examination of the adverse event related to influenza virus vaccines in children with idiopathic nephrotic syndrome

Scientific Title

Examination of the adverse event related to influenza virus vaccines in children with idiopathic nephrotic syndrome

Scientific Title:Acronym

Examination of the adverse event related to influenza virus vaccines in children with idiopathic nephrotic syndrome

Region

Japan


Condition

Condition

idiopathic nephrotic syndrome

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the relapse of nephrotic syndrome or other adverse effect related to influenza virus vaccines in children with idiopathic nephrotic syndrome

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relapse rate of nephrotic syndrome within 1 month after influenza virus vaccines compared with those in 6 months before influenza virus vaccines

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

1 years-old <=

Age-upper limit

18 years-old >=

Gender

Male and Female

Key inclusion criteria

Children diagnosed as idiopathic nephrotic syndrome

Key exclusion criteria

Children diagnosed as any nephritis or secondary nephrotic syndrome, and experienced allergic reaction related influenza virus vaccine

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shingo Ishimori

Organization

Kakogawa central city hospital

Division name

Department of pediatrics

Zip code


Address

439, Honmachi, Kakogawa-cho, Kakogawa, Hyogo

TEL

0794515500

Email

shingo-i0324os@live.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shingo Ishimori

Organization

Kakogawa central city hospital

Division name

Department of pediatrics

Zip code


Address

439, Honmachi, Kakogawa-cho, Kakogawa, Hyogo

TEL

0794515500

Homepage URL


Email

shingo-i0324os@live.jp


Sponsor or person

Institute

Kakogawa central city hospital

Institute

Department

Personal name



Funding Source

Organization

Kakogawa central city hospital

Organization

Division

Category of Funding Organization

Other

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

加古川中央市民病院 小児科、神戸大学大学院医学研究科 内科系講座小児科学分野、国立成育医療研究センター 腎臓リウマチ膠原病科、兵庫県立こども病院 腎臓内科、高槻病院 小児科、北播磨総合医療センター 小児科、姫路赤十字病院 小児科


Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 14 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

2017 Year 07 Month 19 Day

Date of IRB


Anticipated trial start date

2017 Year 08 Month 14 Day

Last follow-up date

2018 Year 07 Month 31 Day

Date of closure to data entry

2018 Year 07 Month 31 Day

Date trial data considered complete

2018 Year 07 Month 31 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information

This is prospective observational study in multi center


Management information

Registered date

2017 Year 08 Month 14 Day

Last modified on

2018 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032804


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name