UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007511
Receipt No. R000008839
Scientific Title Mycophenolate mofetil treatment in a patient with frequently relapsing nephrotic syndrome
Date of disclosure of the study information 2012/04/01
Last modified on 2014/08/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Mycophenolate mofetil treatment in a patient with frequently relapsing nephrotic syndrome
Acronym Mycophenolate mofetil treatment in a patient with frequently relapsing nephrotic syndrome
Scientific Title Mycophenolate mofetil treatment in a patient with frequently relapsing nephrotic syndrome
Scientific Title:Acronym Mycophenolate mofetil treatment in a patient with frequently relapsing nephrotic syndrome
Region
Japan

Condition
Condition frequently relapsing nephrotic syndrome
Classification by specialty
Nephrology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate the efficacy of mycophenolate mofetil in a patient with
frequently relapsing nephrotic syndrome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to frequent relapse
Key secondary outcomes Time to relapse
side effect

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 Administration of mycophenolate mofetil 500 to 1000mg 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
12 years-old <=
Age-upper limit
18 years-old >=
Gender Male
Key inclusion criteria frequently relapsing nephrotic syndrome
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 Life Sciences
Division name Department of Pediatrics
Zip code
Address 1-1-1 Honjo, Kumammoto 860-8556, Japan
TEL 096-373-5188
Email fendo@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Nakazato
Organization Kumamoto University, Faculty of Life Sciences
Division name Department of Pediatrics
Zip code
Address 1-1-1 Honjo, Kumammoto 860-8556, Japan
TEL 096-373-5191
Homepage URL
Email hnakazat@fc.kuh.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University, Faculty of Life Sciences, 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 熊本大学医学部附属病院(熊本県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 01 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
2012 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 15 Day
Last modified on
2014 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008839

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.