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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027397
Receipt No. R000031397
Scientific Title CellCept 250 Special Drug Use Surveillance, Lupus nephritis
Date of disclosure of the study information 2017/06/05
Last modified on 2019/03/27

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Basic information
Public title CellCept 250 Special Drug Use Surveillance, Lupus nephritis
Acronym CellCept 250 Special Drug Use Surveillance, Lupus nephritis
Scientific Title CellCept 250 Special Drug Use Surveillance, Lupus nephritis
Scientific Title:Acronym CellCept 250 Special Drug Use Surveillance, Lupus nephritis
Region
Japan

Condition
Condition Lupus nephritis
Classification by specialty
Nephrology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To ascertain the safety and effectiveness of CellCept in post-marketing use for patients with lupus nephritis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse reaction incidence
Rate of achieving for the treatment by evaluation items eGFR, etc.
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 The naive patients for Celcept,after diagnosed as SLE and LN on the basis of the ACR's criterion
Key exclusion criteria Not applicable
Target sample size 550

Research contact person
Last name of lead principal investigator
1st name Izumi
Middle name
Last name Kawashima
Organization Chugai Pharmaceutical Co. Ltd.
Division name Real World Data Science Dept.
Zip code 1038324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-2377
Email kawashimaizm@chugai-pharm.co.jp

Public contact
1st name of contact person
1st name Ayaka
Middle name
Last name Shimizu
Organization Chugai Pharmaceutical Co. Ltd.
Division name Real World Data Science Dept.
Zip code 1038324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0905
Homepage URL
Email shimizuayk@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co. Ltd.
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization None
Address None
Tel None
Email None

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
2017 Year 06 Month 05 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 No longer recruiting
Date of protocol fixation
2017 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Adverse events
eGFR,Uric protein ,Creatinine,Creatinine ratio,time course of Celcept/corticosteroids dose,ratio of exacerbation

Management information
Registered date
2017 Year 05 Month 19 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031397

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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