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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028658
Receipt No. 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

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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
Institute Kakogawa central city hospital
Institute
Department

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
URL(English) https://upload.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


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