UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021582 |
|---|---|
| Receipt number | R000024890 |
| Scientific Title | Efficacy and safety using optimization MMF of dosing by monitoring |
| Date of disclosure of the study information | 2016/03/23 |
| Last modified on | 2019/03/14 14:00:36 |
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Basic information
Public title
Efficacy and safety using optimization MMF of dosing by monitoring
Acronym
Efficacy and safety using optimization MMF of dosing by monitoring
Scientific Title
Efficacy and safety using optimization MMF of dosing by monitoring
Scientific Title:Acronym
Efficacy and safety using optimization MMF of dosing by monitoring
Region
| Japan |
Condition
Condition
Renal-transplant recipients and liver-transplant recipients and refractry GVHD
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the proper dosage in the patients receiving MMF by monitoring.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetic analysis of MPAG and MPA
Key secondary outcomes
Efficacy and safety
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 administration
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who receive mycophenolate mofetil.
Key exclusion criteria
The patients who do not obtain consent for this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryosei nishimura |
Organization
Kanazawa universuty
Division name
Pediatrics
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2313
pedialib@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Maeba |
Organization
Kanazawa University
Division name
Pediatrics
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2313
Homepage URL
pedialib@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Kanazawa University.
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Kanazawa 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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 23 | 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
| 2011 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 23 | Day |
Last modified on
| 2019 | 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=R000024890
| 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 |
