UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015051
Receipt number R000010173
Scientific Title Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome
Date of disclosure of the study information 2014/09/04
Last modified on 2019/02/16 13:19:44

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Basic information

Public title

Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome

Acronym

Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome

Scientific Title

Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome

Scientific Title:Acronym

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

1st name
Middle name
Last name Kimitoshi Nakamura

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Pediatrics

Zip code


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

1st name
Middle name
Last name Hitoshi Nakazato

Organization

Faculty of Education, Kumamoto University

Division name

Department of School Health

Zip code


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 or person

Institute

Department of Pediatrics, Faculty of Life Sciences, Kumamoto University

Institute

Department

Personal name



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)



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

2014 Year 09 Month 04 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

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.

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 08 Month 11 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010173


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name