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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-C000000009 |
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Date of registration:
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01/08/2005 |
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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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Treatment for steroid-resistant nephrotic syndrome in children: a combination of cyclosporine and prednisolone in minimal change and a combination of methylprednisolone, cyclosporine and prednisolone in FSGS
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Scientific title:
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Treatment for steroid-resistant nephrotic syndrome in children: a combination of cyclosporine and prednisolone in minimal change and a combination of methylprednisolone, cyclosporine and prednisolone in FSGS - Treatment for steroid-resistant nephrotic syndrome in children: a combination of cyclosporine and prednisolone in minimal change and a combination of methylprednisolone, cyclosporine and prednisolone in FSGS |
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Date of first enrolment:
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2001/04/01 |
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Target sample size:
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60 |
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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=R000000014 |
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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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Masataka Honda |
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Address:
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4-33-13 Daimachi Hachioji City,Tokyo
Japan |
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Telephone:
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Email:
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Affiliation:
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Tokyo Metropolitan Children's Hospital Department of Pediatrics |
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Name:
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Address:
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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 Department of Nephrology, Tokyo Metropolitan Children's Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1.Congenital nephrotic syndrome. 2.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus). 3.Medical history of allergy or hypersensitivity reactions to methylprednisolone and cyclosporine. 4.Poorly controlled hypertension. 5.Chronic renal dysfunction. 6.Active infectious disease. 7.Severe liver disfunction. 8.History of cyclosporine administration. 9.Pregnancy. 10.Judged inappropriate for this study by the physicians.
Age minimum:
1years-old
Age maximum:
18years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Steroid-resistant nephrotic syndrome in children
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Intervention(s)
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Cyclosporine+prednisolone Methylprednisolone+cyclosporine+prednisolone
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Primary Outcome(s)
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Complete remission rate
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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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01/05/2007 |
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URL:
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