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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:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000013694
Date of registration:	11/04/2014
Prospective Registration:	Yes
Primary sponsor:	Kitasato University Kitasato Institute Hospital
Public title:	Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs
Scientific title:	Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs - Tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs
Date of first enrolment:	2014/05/13
Target sample size:	30
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015986
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Taku Kobayashi
Address:	5-9-1 Shirokane, Minato-ku, Tokyo Japan
Telephone:	03-3444-6161
Email:	kobataku@insti.kitasato-u.ac.jp
Affiliation:	Kitasato University Kitasato Institute Hospital Center for Advanced IBD Research and Treatment

Name:	Taku Kobayashi
Address:	5-9-1 Shirokane, Minato-ku, Tokyo Japan
Telephone:	03-3444-6161
Email:	kobataku@insti.kitasato-u.ac.jp
Affiliation:	Kitasato University Kitasato Institute Hospital Center for Advanced IBD Research and Treatment

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1. women who are pregnant, breastfeeding, or possible to be pregnant 2. individuals who are considered ineligible by the investigator

Age minimum: 18years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

ulcerative colitis

Intervention(s)

determine CYP3A5 SNP status increase the initial dosage of tacrolimus

Primary Outcome(s)

efficacy on day 7

Secondary Outcome(s)

blood concentration on day 3 time to reach the target concentration (10ng/ml)

Secondary ID(s)

Source(s) of Monetary Support

Kitasato University Kitasato Institute Hospital

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date: 13/05/2014
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2021
URL:

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