UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002796
Receipt number R000002658
Scientific Title Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial.
Date of disclosure of the study information 2009/11/25
Last modified on 2013/12/29 14:46:49

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Basic information

Public title

Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial.

Acronym

Clinical trial of tacrolimus for patients with Crohn's disease

Scientific Title

Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial.

Scientific Title:Acronym

Clinical trial of tacrolimus for patients with Crohn's disease

Region

Japan


Condition

Condition

Crohn's disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the efficacy and safty of tactolimus therapy in patiets with active Crohn's disease refractory to or intolerant of azathioprine(6-MP) and /or inflixmab

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Crohn's disease activity index at 0.4.8 weeks after treatment

Key secondary outcomes

(1)change of CRP
(2)percentage of patients achieved remission after treatment
(3)safty
(4)percentage of pateints with decreasing more than 100 points of CDAI after treatment


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We randomly assigned patients into either placebo or tacrolimus group at a ratio of 1:1 by use of stratified block randomization. Patients assigned to tacrolimus received for four weeks.
For induction of remission, the dose of tacrolimus is increased with aiming at high trough level (10~15ng/ml).

Interventions/Control_2

placebo control

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

16 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

220 < CDAI <450

Key exclusion criteria

(1)patients with severe active disease-massive bleeding case, perforating case(2)patients with severe cardiac disease, liver disease, respiratory disease
(3)patients with renal disease and hyperkalemia
(4)patients with malignant disease, history of malignancy
(5)patients with severe infection
(6)patient having pregnancy or having the possiblity of pregnancy

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chiba Tsutomu

Organization

Kyoto University

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyoku, Kyoto

TEL

075-751-4319

Email

chiba@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Nakase

Organization

Kyoto University

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyoku, Kyoto

TEL

075-751-4319

Homepage URL


Email

hiropy_n@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

the Ministry of Health, Labor, and Welfare, Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

2009 Year 11 Month 25 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

Open public recruiting

Date of protocol fixation

2009 Year 09 Month 14 Day

Date of IRB


Anticipated trial start date

2009 Year 11 Month 01 Day

Last follow-up date

2015 Year 12 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

2009 Year 11 Month 24 Day

Last modified on

2013 Year 12 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002658


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name