UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005242 |
|---|---|
| Receipt number | R000006235 |
| Scientific Title | Efficacy and safety of low dose mycophenolate mofetile for remission maintenance in ANCA-associated vasculitis |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2011/03/14 12:48:02 |
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Basic information
Public title
Efficacy and safety of low dose mycophenolate mofetile for remission maintenance in ANCA-associated vasculitis
Acronym
Low dose mycophenolate mofetile as maintenance therapy in ANCA-associated vasculitis
Scientific Title
Efficacy and safety of low dose mycophenolate mofetile for remission maintenance in ANCA-associated vasculitis
Scientific Title:Acronym
Low dose mycophenolate mofetile as maintenance therapy in ANCA-associated vasculitis
Region
| Japan |
Condition
Condition
ANCA associated vasculitis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of mychophenolate mofetile as maintenace therapy in patients with ANCA associated vasculitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
relapse rate
Key secondary outcomes
1,side effect of steroid
2,safety of MMF
3,VDI, SF36, QOL
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
MMF 500~1000mg/day
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
ANCA associated vasculitis
state of remission
patients gave written informed consent for participation in the study
Key exclusion criteria
WBC<3000/mm3
pregnant women
combine with other immunosuppressant within 4 weeks
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kosaku Nitta |
Organization
Kidney Center, Tokyo Women's Medical University
Division name
Department of Medicine
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuyo Itabashi |
Organization
Kidney Center, Tokyo Women's Medical University
Division name
Department of Medicine
Zip code
Address
8-1 kawada-cho, shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
Homepage URL
m-itaba@fb4.so-net.ne.jp
Sponsor or person
Institute
Department of Medicine, Kidney Center, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine, Kidney Center, Tokyo Women's Medical University
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | 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 | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 14 | Day |
Last modified on
| 2011 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006235
