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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005033
Receipt No. R000005985
Scientific Title Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis
Date of disclosure of the study information 2011/03/01
Last modified on 2018/01/02

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Basic information
Public title Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis
Acronym Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis
Scientific Title Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis
Scientific Title:Acronym Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to compare the efficacy between tacrolimus and tacrolimus with GMA in a single center, prospective, randomized, controlled, non-blinded study for active ulcerative colitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The primary measure of response was clinical remission at 3- week, CAI 4 or less
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 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))
Interventions/Control_2 Patiens in tacrolimus with GMA receive tacrolimus twice a day and two GMA treatments per week.
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
12 years-old <
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Active disease defined as a CAI 6 or more
Able to provide informed consent
Key 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
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Kato
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1981 Kamoda, Kawagoe City, Saitama, Japan
TEL 049-228-3564
Email skato@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Kato
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1981 Kamoda, Kawagoe City, Saitama, Japan
TEL 049-228-3564
Homepage URL
Email skato@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical University
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
2011 Year 03 Month 01 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 Completed
Date of protocol fixation
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 05 Day
Last modified on
2018 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005985

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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