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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021582
Receipt No. 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

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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
Email 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
Email pedialib@med.kanazawa-u.ac.jp

Sponsor
Institute Department of Pediatrics, Kanazawa University.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024890

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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