UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024646 |
|---|---|
| Receipt number | R000028353 |
| Scientific Title | Influenza vaccination for patients with complicated nephrotic syndrome treated with rituximab |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2017/09/17 12:02:42 |
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Basic information
Public title
Influenza vaccination for patients with complicated nephrotic syndrome treated with rituximab
Acronym
Influenza vaccination for patients with nephrotic syndrome
Scientific Title
Influenza vaccination for patients with complicated nephrotic syndrome treated with rituximab
Scientific Title:Acronym
Influenza vaccination for patients with nephrotic syndrome
Region
| Japan |
Condition
Condition
Complicated nephrotic syndrome treated with rituximab
Classification by specialty
| Nephrology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy and safety of influenza vaccines for patients with complicated nephrotic syndrome who has been treated with rituximab in the recent one year.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
MFI(mean fold increase) of GMT(geometric mean titer) of one month and three months after vaccination compared with that before vaccination.
Key secondary outcomes
1) Relationship between B-cell counts and MFI.
2) Relationship between period after the rituximab treatment and MFI.
3) Seroconversion rate of one month and three months after vaccination compared with that before vaccination.
4) Relationship between B-cell counts and seroconversion rate.
5) Relationship between period after the rituximab treatment and seroconversion rate.
6) Seroprotection rate of one month and three months after vaccination.
7) Relationship between B-cell counts and seroprotection rate.
8) Relationship between period after the rituximab treatment and seroprotection rate.
9) Relapses of nephrotic syndrome after vaccination.
10) Adverse events after vaccination.
11) Occurence of influenza infections.
12) Occurence of life-threatening influenza infections.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
Influenza vaccines
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with complicated nephrotic syndrome who has been treated with rituximab in one year.
Key exclusion criteria
Patients who do not agree for the entry of the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Kamei |
Organization
National Center for Child Health and Development
Division name
Division of Nephrology and Rheumatology
Zip code
Address
2-10-1, Okura, Setagaya-ku, Tokyo
TEL
03-5494-7128
kamei-k@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Kamei |
Organization
National Center for Child Health and Development
Division name
Division of Nephrology and Rheumatology
Zip code
Address
2-10-1, Okura, Setagaya-ku, Tokyo
TEL
03-5494-7128
Homepage URL
kamei-k@ncchd.go.jp
Sponsor or person
Institute
Division of Nephrology and Rheumatology, National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
No orgatnization for funding source.
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
国立成育医療研究センター 腎臓リウマチ膠原病科
東京都立小児総合医療センター 腎臓内科
久留米大学病院 小児科
横浜市立大学市民総合医療センター 小児科
東京医科歯科大学 小児科
埼玉小児総合医療センター 腎臓科
国立病院機構千葉東病院 小児科
静岡こども病院 腎臓内科
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 31 | Day |
Last modified on
| 2017 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028353
