UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influenza vaccination for patients with complicated nephrotic syndrome treated with rituximab
Title of the study (Brief title)	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	Koichi Kamei
Organization	National Center for Child Health and Development
Division name	Division of Nephrology and Rheumatology
Address	2-10-1, Okura, Setagaya-ku, Tokyo
TEL	03-5494-7128
Email	kamei-k@ncchd.go.jp

Public contact
Name of contact person	Koichi Kamei
Organization	National Center for Child Health and Development
Division name	Division of Nephrology and Rheumatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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