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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-UMIN000005033 |
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Date of registration:
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01/03/2011 |
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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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Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis
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Scientific title:
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Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis - Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis |
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Date of first enrolment:
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2011/03/01 |
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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=R000005985 |
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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 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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Shingo Kato |
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Address:
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1981 Kamoda, Kawagoe City, Saitama, Japan
Japan |
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Telephone:
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049-228-3564 |
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Email:
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skato@saitama-med.ac.jp |
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Affiliation:
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Saitama Medical Center, Saitama Medical University Department of Gastroenterology and Hepatology |
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Name:
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Shingo Kato |
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Address:
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1981 Kamoda, Kawagoe City, Saitama, Japan
Japan |
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Telephone:
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049-228-3564 |
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Email:
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skato@saitama-med.ac.jp |
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Affiliation:
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Saitama Medical Center, Saitama Medical University Department of Gastroenterology and Hepatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Granulocyte count is equal to or less than 2,000/mm3 Serious infectious disease Patients who has a allergic history against tacrolimus Patients who receive cyclosporine and/or bozentan Patients who receive potassium-sparing diuretic Pregnancy
Age minimum:
12years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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ulcerative colitis
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Intervention(s)
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Patients in tacrolimus only receive tacrolimus twice a day (at initial dose of 0.0025mg/kg, optimal serum traff level 10-15ng/ml (until 2 weeks) , 5-10ng/ml (after 2 weeks))
Patiens in tacrolimus with GMA receive tacrolimus twice a day and two GMA treatments per week.
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Primary Outcome(s)
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The primary measure of response was clinical remission at 3- week, CAI 4 or less
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Secondary Outcome(s)
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Clinical remission at 2, 4, 6 week Clinical response at each week, decrease of 3 and more points from initial CAI Reduction in CRP Reduction in CAI Induction time to remission Safety assessment
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Source(s) of Monetary Support
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Saitama Medical Center, Saitama Medical University
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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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Date Posted:
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Date Completed:
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URL:
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