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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-UMIN000022150 |
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Date of registration:
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01/05/2016 |
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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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The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome.
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Scientific title:
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The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome. - The study on efficacy and safety of rituximab for adult and geriatric patients with nephrotic syndrome. |
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Date of first enrolment:
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2016/04/30 |
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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=R000025524 |
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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 applicable
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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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Takashi
Takei |
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Address:
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35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan
1730015
Japan |
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Telephone:
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03-3964-1982 |
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Email:
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takashi_takei@tmghig.jp |
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Affiliation:
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Tokyo Metropolitan Geriatric Hospital Nephrology |
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Name:
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Takasi
Takei |
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Address:
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35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3964-1982 |
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Email:
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takashi_takei@tmghig.jp |
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Affiliation:
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Tokyo Metropolitan Geriatric Hospital Nephrology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Case that showed at least one of the following terms should be excluded. 1)Patient who have the severe allergy for rituximab. 2)Patient who has the severe disease, such as heart failure,liver diseases(hepatitis B positive)and end stage renal disease. 3)Patient who has the severe bacterial,fungal or viral infection. 4)Patient who could not experienced informd consent. 5)The doctor decides that the patient is inappropriate to enroll in this study.
Age minimum:
18years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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primary nephrotic syndrome
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Intervention(s)
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rituximab
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Primary Outcome(s)
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Rate of remission from nephrotic syndrome
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Secondary Outcome(s)
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1.Rate of continuity of the selected treatment. 2. The reduction of the degree of proteinuria. 3. Frequency of adverse complication derived from drug use. 4. Total dose of prednisolone and immunosuppressant agents for treatment of nephrotic syndrome. 5. Changes in the renal function
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Source(s) of Monetary Support
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Tokyo Metropolitan Geriatric Hospital
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Ethics review
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Status: YES
Approval date: 13/05/2016
Contact:
takashi_takei@tmghig.jp
Tokyo Metropolitan Geriatric Hospital
03-3964-1982
takashi_takei@tmghig.jp
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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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31/03/2019 |
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URL:
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