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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002740
Receipt No. 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

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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
Email

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
Email hnakazat@fc.kuh.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University, Department of Pediatrics
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003332

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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