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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014997
Receipt No. R000017445
Scientific Title Rituxan injection drug use-results survey in patients with complicated nephrotic syndrome
Date of disclosure of the study information 2014/08/29
Last modified on 2019/03/05

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Basic information
Public title Rituxan injection drug use-results survey in patients with complicated nephrotic syndrome
Acronym Rituxan injection drug use-results survey in patients with complicated nephrotic syndrome
Scientific Title Rituxan injection drug use-results survey in patients with complicated nephrotic syndrome
Scientific Title:Acronym Rituxan injection drug use-results survey in patients with complicated nephrotic syndrome
Region
Japan

Condition
Condition nephrotic symdrome
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety and effectiveness of Rituxan in patients with complicated nephrotic symdrome (frequently relapsing or steroid-dependent subtype)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Adverse drug reaction occurrences
Relapse-free period
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All the patients who have received rituximab for nephrotic syndrome
Key exclusion criteria None
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shohji Kimura
Organization Zenyaku Kogyo, Co., Ltd.
Division name Post-Marketing-Surveillance Pharmacovigilance & Quality Assurance Department
Zip code
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650
TEL 03-3946-1136
Email Shohji_Kimura@mail.zenyaku.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shohji Kimura
Organization Zenyaku Kogyo, Co., Ltd.
Division name Post-Marketing-Surveillance Pharmacovigilance & Quality Assurance Department
Zip code
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650
TEL 03-3946-1136
Homepage URL
Email Shohji_Kimura@mail.zenyaku.co.jp

Sponsor
Institute Zenyaku Kogyo, Co., Ltd.
Institute
Department

Funding Source
Organization Zenyaku Kogyo, Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Chugai Pharmaceutical Co., Ltd.
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

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 29 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
2014 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 29 Day
Last follow-up date
2018 Year 10 Month 15 Day
Date of closure to data entry
2018 Year 11 Month 30 Day
Date trial data considered complete
2018 Year 11 Month 30 Day
Date analysis concluded
2019 Year 02 Month 27 Day

Other
Other related information Safety, Efficacy

Management information
Registered date
2014 Year 08 Month 29 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017445

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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