UMIN-CTR Clinical Trial

Basic information
Public title	Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs
Acronym	Tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs
Scientific Title	Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs
Scientific Title:Acronym	Tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the clinical usefulness of determining the initial dosage of tacrolimus based on the SNPs status of CYP3A5
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	efficacy on day 7
Key secondary outcomes	blood concentration on day 3 time to reach the target concentration (10ng/ml)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Gene
Interventions/Control_1	determine CYP3A5 SNP status increase the initial dosage of tacrolimus
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. individuals brom whom written informed consent was obtained 2. >=18 years old 3. patients who are going to take tacrolimus
Key exclusion criteria	1. women who are pregnant, breastfeeding, or possible to be pregnant 2. individuals who are considered ineligible by the investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Taku Kobayashi
Organization	Kitasato University Kitasato Institute Hospital
Division name	Center for Advanced IBD Research and Treatment
Zip code
Address	5-9-1 Shirokane, Minato-ku, Tokyo
TEL	03-3444-6161
Email	kobataku@insti.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Taku Kobayashi
Organization	Kitasato University Kitasato Institute Hospital
Division name	Center for Advanced IBD Research and Treatment
Zip code
Address	5-9-1 Shirokane, Minato-ku, Tokyo
TEL	03-3444-6161
Homepage URL
Email	kobataku@insti.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University Kitasato Institute Hospital
Institute
Department

Funding Source
Organization	Kitasato University Kitasato Institute Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 04 Month 20 Day
Date of IRB	2014 Year 05 Month 13 Day
Anticipated trial start date	2014 Year 05 Month 13 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 11 Day
Last modified on	2020 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015986