UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000378
Receipt number R000000464
Scientific Title A combination of methylprednisolone and prednisolone and a combination of Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04)
Date of disclosure of the study information 2006/04/01
Last modified on 2014/03/14 10:06:05

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Basic information

Public title

A combination of methylprednisolone
and prednisolone and a combination of
Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04)

Acronym

A combination of methylprednisolone and prednisolone and a combination of
methylprednisolone, prednisolone and mizoribine: A randomized controlled trial (JSRDC04)

Scientific Title

A combination of methylprednisolone
and prednisolone and a combination of
Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04)

Scientific Title:Acronym

A combination of methylprednisolone and prednisolone and a combination of
methylprednisolone, prednisolone and mizoribine: A randomized controlled trial (JSRDC04)

Region

Japan


Condition

Condition

systematic lupus erythematosus

Classification by specialty

Clinical immunology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

By comparing prednisolone only and a combination of prednisolone and mizoribine, the better is selected as a standard treatment for systematic lupus erythematosus in children.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cumulative flare rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Methylprednisolone+prednisolone

Interventions/Control_2

Methylprednisolone+prednisolone+mizoribine

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

2 years-old <=

Age-upper limit

18 years-old >=

Gender

Male and Female

Key inclusion criteria

1.First diagnoses of systematic lupus erythematosus based on guidline defined by children collagen disease study group in Health and Welfare Ministry.
2.Aged two years to 18 years.
3.Written informed consent from the patients' parents or legal guardians.

Key exclusion criteria

1.Chronic rheumatoid arthritis, diffuse scleroderma or dermatomyositis.
2.History of immunosuppressive drugs administration.
3.Medical history of allergy or hypersensitivity reactions to mizoribine.
4.Poorly controlled hypertension.
5.Active infectious disease.
6.Severe liver disfunction.
7.Pregnancy.
8.Judged inappropriate for this study by the physicians.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masataka Honda

Organization

Tokyo Metropolitan Children's Hospital

Division name

Department of Pediatrics

Zip code


Address

4-33-13 Daimachi Hachioji City,Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Japanese Study Group of Renal Disease in Children(JSRDC)

Division name

Department of Nephrology, Tokyo Metropolitan Children's Hospital

Zip code


Address

1-3-1 Umezono Kiyose City, Tokyo

TEL


Homepage URL


Email



Sponsor or person

Institute

Japanese Study Group of Renal Disease in Children(JSRDC)

Institute

Department

Personal name



Funding Source

Organization

The Kidney Foundation, Japan

Organization

Division

Category of Funding Organization

Non profit foundation

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

2006 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

1995 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

1995 Year 03 Month 01 Day

Last follow-up date

2004 Year 04 Month 01 Day

Date of closure to data entry

2004 Year 07 Month 01 Day

Date trial data considered complete

2004 Year 07 Month 01 Day

Date analysis concluded

2004 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2006 Year 03 Month 29 Day

Last modified on

2014 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000464


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name