UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024646
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kamei-k@ncchd.go.jp

Sponsor
Institute Division of Nephrology and Rheumatology, National Center for Child Health and Development
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028353

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.