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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006080
Receipt No. R000007194
Scientific Title Uncontrol trial of targeted therapy on chronic glomerulonephritis
Date of disclosure of the study information 2011/08/01
Last modified on 2011/07/29

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Basic information
Public title Uncontrol trial of targeted therapy on chronic glomerulonephritis
Acronym Uncontrol trial of targeted therapy on chronic glomerulonephritis
Scientific Title Uncontrol trial of targeted therapy on chronic glomerulonephritis
Scientific Title:Acronym Uncontrol trial of targeted therapy on chronic glomerulonephritis
Region
Japan

Condition
Condition chronic glomerulonephritis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects and safety of targeted therapy on chronic blomerulonephritis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes urinalysis, the cumulative dose of prednisolone and the cumulative dose of immunosuppressive drugs
Key secondary outcomes the adverse effects of prednisolone, the adverse effects of immunosuppressive drugs, the adverse effects of targeted therapy

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
Medicine
Interventions/Control_1 Rituximab 375mg/2 once a week total 4 times, tocilizumab 8 mg/kg once a month total 3 times, or abatacept 500mg once a month total 7 times, 24 months follow-up
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria chronic glomerulonephritis on biopsy,
rebellant,
patients with participation after written informed concent
Key exclusion criteria Patients with positive serology for hepatitis B, C or HIV,
severe renal dysfunction,
severe liver dysfunction,
pregnant woman
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Toya
Organization Yokohama City University Hospital
Division name Department of Nephrology and Hypertension
Zip code
Address Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuo Hashimoto
Organization Yokohama City University Hospital
Division name Department of Nephrology and Hypertension
Zip code
Address Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa
TEL
Homepage URL
Email

Sponsor
Institute Department of Cardiorenal Medicine, Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Hospital
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 01 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 Open public recruiting
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 29 Day
Last modified on
2011 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007194

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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