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
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
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
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
