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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-UMIN000000621 |
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Date of registration:
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28/02/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission
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Scientific title:
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Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission - ONTRACK |
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Date of first enrolment:
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2007/03/01 |
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Target sample size:
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50 |
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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=R000000753 |
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Study type:
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Interventional |
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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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Hirofumi Makino |
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Address:
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2-5-1 Shikata-cho, Okayama 700-8558, Japan
Japan |
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Telephone:
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086-235-7235 |
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Email:
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hitoshis@md.okayama-u.ac.jp |
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Affiliation:
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Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan Department of Medicine and Clinical Science |
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Name:
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Hitoshi Sugiyama |
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Address:
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2-5-1 Shikatacho Kitaku, Okayama, Japan
Japan |
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Telephone:
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086-235-7235 |
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Email:
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sannai@cc.okayama-u.ac.jp |
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Affiliation:
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Okayama University Graduate School, Okayama, Japan Department of Medicine and Clinical Science |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Renal dysfunction (Ccr under 30 ml/min) 2) Histry of taking immunosuppressant within one month 3) Patients with malignant disease 4) Malabsorption syndrome or epilepsy 5) Severe heart, liver, or pancreatic disaese 6) Active infectious disease 7) Pregnancy 8) Hypersensitivity to cyclosporin 9) Hypersensitivity to ARB 10) Patients with FSGS 11) Others
Age minimum:
16years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Minimal change nephrotic syndrome
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Intervention(s)
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Prednisolone (+), combination therapy (-)
Prednisolone (+), combination therapy (+)
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Primary Outcome(s)
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The number of relapse after initial treatment and the duration of remission before the relapse
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Source(s) of Monetary Support
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Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, 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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01/03/2011 |
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URL:
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