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
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
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
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
