UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013694 |
|---|---|
| Receipt number | R000015986 |
| Scientific Title | Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs |
| Date of disclosure of the study information | 2014/04/11 |
| Last modified on | 2020/04/16 14:23:44 |
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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
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
kobataku@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015986
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
