UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000378
Receipt No. 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

* 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 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
Institute Japanese Study Group of Renal Disease in Children(JSRDC)
Institute
Department

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
URL(English) https://upload.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


Contact us.