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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-UMIN000001099 |
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Date of registration:
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31/03/2008 |
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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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Optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome
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Scientific title:
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Optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome - Optimal use of ciclosporin in membranous nephropathy (OCIM-NS study) |
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Date of first enrolment:
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2007/10/01 |
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Target sample size:
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50 |
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Recruitment status: |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001321 |
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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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Phase IV
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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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Takeshi Nakanishi |
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Address:
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1-1, Mukogawa, NIshinomiya, Hyogo, Japan
Japan |
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Telephone:
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0798-45-6521 |
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Email:
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Affiliation:
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Hyogo College of Medicine Division of Kidney and Dialysis, Department of Internal Medicine |
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Name:
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Masaaki Izumi |
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Address:
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1-1, Mukogawa, NIshinomiya, Hyogo, Japan
Japan |
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Telephone:
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0798-45-6521 |
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Email:
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izumi@hyo-med.ac.jp |
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Affiliation:
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Hyogo College of Medicine Division of Kidney and Dialysis, Department of Internal Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: The cases who are considered inappropriate under "Guideline of ciclosporin therapy in nephrotic syndrome" or each doctor's decisions.
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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idiopathic membranous nephropathy associated with nephrotic syndrome
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Intervention(s)
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Steroid group: Immunosuppressive therapy is started by predonisolone 0.8mg/kg/day (max 60mg/day). The dose is decreased by 5mg/day in 2 to 4 weeks after remission. The cases who do not reach remission for 4 weeks, predonisolone is decreased to 0.6mg/kg/day, and ciclosporin (2mg/kg/day) is started once a day. Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.)
Steroid + ciclosporin group: Immunosupressive therapy is started by predonisolone 0.6mg/kg/day and ciclosporin 2mg/kg/day (once a day). Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.) The dose of predonisolone is decreased by 5mg/day in 2 to 4 weeks after remission. Ciclosporin is continued after remission. (The target C2 is 600-800 ng/mL.) The cases who do not reach remission after 4 weeks, predonisolone is decreased by 5mg/4-8week, and ciclosporin is continued for 6 months. The target C2 is 800-1000ng/mL. At 6 months after, the therapy of non-respnder is not restricted.
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Primary Outcome(s)
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quantity of urinary protein, frequency of relapse, renal function (serum Cr, estimated GFR),time to remission, total dose of steroid (until remission)
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Secondary Outcome(s)
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adverse effects of steroid and ciclosporin, total dose of steroid (in all treatment period), duration of hospitalization, serum albumin, serum total protein, serum total cholesterol, degree of edema
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Source(s) of Monetary Support
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none
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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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01/07/2010 |
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URL:
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