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. |
Register:
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JPRN |
Last refreshed on:
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17 October 2023 |
Main ID: |
JPRN-C000000363 |
Date of registration:
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14/05/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A combination of prednisolone and mizoribine and a combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with diffuse mesangial prolideration in children:A randomized controlled trial of efficacy and safety
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Scientific title:
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A combination of prednisolone and mizoribine and a combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with diffuse mesangial prolideration in children:A randomized controlled trial of efficacy and safety - A combination of prednisolone and mizoribine and a combination of prednisolone, mizoribine, warfarin and dipyridamole: A randomized controlled trial(JPIGANTS01) |
Date of first enrolment:
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2001/08/01 |
Target sample size:
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80 |
Recruitment status: |
Complete: follow-up complete |
URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000435 |
Study type:
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Interventional |
Study design:
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Parallel 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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Norishige Yoshikawa |
Address:
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811-1 Kimiidera Wakayama City Wakayama
Japan |
Telephone:
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Email:
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Affiliation:
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Wakayama Medical University Department of Pediatrics |
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Name:
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Address:
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Japan |
Telephone:
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073-441-633 |
Email:
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Affiliation:
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The Japanese Pediatric IgA Nephropathy of Department of Pediatrics, Wakayama Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1.Systemic diseases defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus, etc) 2.Medical history of allergy or hypersensitivity reactions to prednisolone, mizoribine, warfarin or dipyridamole 3.Chronic renal dysfunction 4.Active infectious disease 5.Severe liver disfunction 6.History of corticosteroid and immunosupressive drug use 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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IgA nephropathy in children
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Intervention(s)
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prednisolone+mizoribine for 2 years prednisolone+mizoribine+warfarin+dipyridamole for 2 years
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Primary Outcome(s)
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Disappearance rate of proteinuria
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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 |
Date Posted:
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Date Completed:
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01/08/2010 |
URL:
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