UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006080 |
|---|---|
| Receipt number | 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 22:56:03 |
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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
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
Sponsor or person
Institute
Department of Cardiorenal Medicine, Yokohama City University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007194
