UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome
Title of the study (Brief title)	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	Kimitoshi Nakamura
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Pediatrics
Address	1-1-1, Honjo, Chuo-ku, Kumamoto 860-8556, Japan
TEL	096-373-5188
Email	nakamura@kumamoto-u.ac.jp

Public contact
Name of contact person	Hitoshi Nakazato
Organization	Faculty of Education, Kumamoto University
Division name	Department of School Health
Address	2-40-1, Kurokami, Chuo-ku, Kumamoto 860-8555, Japan
TEL	096-373-5191
Homepage URL
Email	hnakazat@kuh.kumamoto-u.ac.jp

Sponsor
Institute	Department of Pediatrics, Faculty of Life Sciences, Kumamoto University
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 08 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010173