UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005033 |
|---|---|
| Receipt number | 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 21:32:24 |
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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
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
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005985
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