UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015051 |
|---|---|
| Receipt number | R000010173 |
| Scientific Title | Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome |
| Date of disclosure of the study information | 2014/09/04 |
| Last modified on | 2019/02/16 13:19:44 |
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Basic information
Public title
Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome
Acronym
Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome
Scientific Title
Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome
Scientific Title:Acronym
Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome
Region
| Japan |
Condition
Condition
steroid-resistant nephrotic syndrome
Classification by specialty
| Nephrology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of mycophenolate mofetil for children with steroid-resistant nephrotic syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of remission
Key secondary outcomes
non-relapse term
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
Oral mycophenolate mofetil 20-30 mg/kg divided into two times 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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)children with steroid-resistant nephrotic syndrome
2)to be resistant to immunosuppresive drugs (ciclosporin, mizoribine etc.) or not able to maintain remission as tapering
3)side effects of steroids or immunosuppresive drugs above are present or possible
4)to obtain informed consent
Key exclusion criteria
none
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimitoshi Nakamura |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Pediatrics
Zip code
Address
1-1-1, Honjo, Chuo-ku, Kumamoto 860-8556, Japan
TEL
096-373-5188
nakamura@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Nakazato |
Organization
Faculty of Education, Kumamoto University
Division name
Department of School Health
Zip code
Address
2-40-1, Kurokami, Chuo-ku, Kumamoto 860-8555, Japan
TEL
096-373-5191
Homepage URL
hnakazat@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
patients
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
| 2014 | Year | 09 | Month | 04 | 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
This clinical trial included 6 patients with steroid resistant nephrotic syndrome.
This clinical trial will discontinue on February 20, 2019, since it cannot be migrated to a particular clinical trial.
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
| 2012 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 20 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 04 | Day |
Last modified on
| 2019 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010173
