UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the adverse event related to influenza virus vaccines in children with idiopathic nephrotic syndrome
Title of the study (Brief title)	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	Shingo Ishimori
Organization	Kakogawa central city hospital
Division name	Department of pediatrics
Address	439, Honmachi, Kakogawa-cho, Kakogawa, Hyogo
TEL	0794515500
Email	shingo-i0324os@live.jp

Public contact
Name of contact person	Shingo Ishimori
Organization	Kakogawa central city hospital
Division name	Department of pediatrics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032804