UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002740 |
|---|---|
| Receipt number | R000003332 |
| Scientific Title | Mycophenolate mofetil treatment for steroid resistant nephrotic syndrome |
| Date of disclosure of the study information | 2009/11/15 |
| Last modified on | 2012/08/11 18:35:23 |
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Basic information
Public title
Mycophenolate mofetil treatment for steroid resistant nephrotic syndrome
Acronym
Mycophenolate mofetil treatment for steroid resistant nephrotic syndrome
Scientific Title
Mycophenolate mofetil treatment for steroid resistant nephrotic syndrome
Scientific Title:Acronym
Mycophenolate mofetil treatment for steroid resistant nephrotic syndrome
Region
| Japan |
Condition
Condition
steroid resistant nephrotic syndrome
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy of mycophenolate mofetil treatment for a patient with steroid resistant nephrotic syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
remission
Key secondary outcomes
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
Mycophenolate mofetil (Cellcept 250mg capsule) 3 to 4 capsule a day.
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Female
Key inclusion criteria
steroid resistant nephrotic syndrome ( no responder who treated with prednisolone 2 mg/kg/day or 60 mg/m2/day for 4 weeks)
Key exclusion criteria
No exclusion criteria
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Endo |
Organization
Kumamoto University, Faculty of Medical and Pharmaceutical Sciences
Division name
Department of Pediatrics
Zip code
Address
1-1-1 Honjo, Kumamoto 860-8556, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Nakazato |
Organization
Kumamoto University, Faculty of Medical and Pharmaceutical Sciences
Division name
Department of Pediatrics
Zip code
Address
1-1-1 Honjo, Kumamoto 860-8556, Japan
TEL
096-373-5191
Homepage URL
hnakazat@fc.kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University, Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
patient
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
熊本大学病院（熊本県）、熊本中央病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 08 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 10 | Day |
Last modified on
| 2012 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003332
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
