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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-C000000159 |
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Date of registration:
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01/04/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mizolibin for systemic lupus erythematosus in children(JSRDC10)
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Scientific title:
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Mizolibin for systemic lupus erythematosus in children(JSRDC10) - Mizolibin for systemic lupus erythematosus in children(JSRDC10) |
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Date of first enrolment:
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2006/03/01 |
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Target sample size:
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30 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000017 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Address:
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2-8-29 Musashinodai, Fuchu-shi, TOKYO, JAPAN
Japan |
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Telephone:
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Email:
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Affiliation:
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Japanese Study Group of Renal Disease in Children(JSRDC) Tokyo Metropolitan Children's Medical Center |
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Name:
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Masataka Honda |
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Address:
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2-8-29 Musashinodai, Fuchu-shi, TOKYO, JAPAN
Japan |
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Telephone:
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Email:
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Affiliation:
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Tokyo Metropolitan Children's Medical Center Department of Pediatric nephrology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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.
Age minimum:
2years-old
Age maximum:
18years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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systematic lupus erythematosus
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Intervention(s)
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Methylprednisolone+mizoribine+prednisolone
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Primary Outcome(s)
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flare proportion
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Source(s) of Monetary Support
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The Kidney Foundation,Japan
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/08/2010 |
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URL:
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