UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004242
Receipt number R000005096
Scientific Title Leukocytapheresis for Maintenance of Remission in Patients with Refractory Inflammatory Bowel Disease: A single-centre, Randomized, Double Blinded Trial
Date of disclosure of the study information 2010/09/21
Last modified on 2014/03/26 18:15:23

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Basic information

Public title

Leukocytapheresis for Maintenance of Remission in Patients with Refractory Inflammatory Bowel Disease: A single-centre, Randomized, Double Blinded Trial

Acronym

Leukocytapheresis as Maintenance of Remission in Patients with Inflammatory Bowel Disease

Scientific Title

Leukocytapheresis for Maintenance of Remission in Patients with Refractory Inflammatory Bowel Disease: A single-centre, Randomized, Double Blinded Trial

Scientific Title:Acronym

Leukocytapheresis as Maintenance of Remission in Patients with Inflammatory Bowel Disease

Region

Japan


Condition

Condition

Ulcerative Colitis

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This is a prospective double-blinded randomized trial with sham column to assess the clinical and/or steroid tapering efficacy of monthly extracorporeal granulocyte/monocyte adsorption (GMA) as maintenance therapy in patients with quiescent UC, who could be induced to clinical remission by applying weekly GMA for 10 consecutive weeks in spite of having steroid refractory background.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

The primary endpoint of the study is a non-relapsing ratio at 48 weeks, relapse is defined if a patient have to start PSL or increase the ongoing dosage, Clinical Activity Index (CAI) ≥ 5.

Key secondary outcomes

To evaluate mucosal UC activity, colonoscopy is done in all patients before and after remission induction therapy. Also, patients who achieve sustained remission at week 48 have colonoscopy at the end of study.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The patients assigned to the True arm, each receives one Adacolumn GMA session every 4 weeks for up to 48 weeks.
The circuit line was covered securely by a curtain to blind both the physician and the patients on the type of treatment.

Interventions/Control_2

The patients assigned to the sham arm, each receives one extracorporeal procedure with the circuit blood lines without the Adacolumn every 4 weeks for up to 48 weeks.
The circuit line was covered securely by a curtain to blind both the physician and the patients on the type of treatment.

Interventions/Control_3

The patients assigned to the control arm, each receives conventional medications without any extracorporeal circulation.

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

Gender and Age; Men and women age 12-75years and body-weight more than 39kg
Disease activity; Quiescent UC (less than 4 points in the clinical activity index established Lichtiger ,et al.) who have finished their remission induction therapy consisted 10 weekly GMA sessions for 10 consecutive weeks within 4 weeks prior to start study.

Key exclusion criteria

Exclusion criteria included therapy with cyclosporine, tacrolimus earlier than 4 weeks prior to start study, infliximab earlier than 8 weeks prior to start study. Also, patients with having granulocytopenia (neutrophil count <2,000/micro-liter), serious heart or kidney disease, coagulation disorder, history of hypersensitivity to heparin or heparin-induced thrombocytopenia, hypotension (<90/65mmHg) or uncontrolled hypertension (>180/ 120mmHg, despite medical therapy; anemia lower than 9.0g/dl in hemoglobin, and women being or wishing pregnant, were excluded.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takayuki Matsumoto

Organization

Hyogo College of Medicine

Division name

Department of Lower Gastroenterology

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo Pref.

TEL

81798456662

Email



Public contact

Name of contact person

1st name
Middle name
Last name Ken Fukunaga

Organization

Hyogo College of Medicine

Division name

Department of Lower Gastroenterology

Zip code


Address


TEL


Homepage URL


Email

kebe@hyo-med.ac.jp


Sponsor or person

Institute

Department of Lower Gastroenterology, Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

兵庫医科大学病院


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 21 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/23170145

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

2004 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2004 Year 04 Month 01 Day

Last follow-up date

2009 Year 12 Month 01 Day

Date of closure to data entry

2010 Year 08 Month 01 Day

Date trial data considered complete

2010 Year 08 Month 01 Day

Date analysis concluded

2010 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 09 Month 21 Day

Last modified on

2014 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005096


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name