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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004242
Receipt No. 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

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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
Institute Department of Lower Gastroenterology, Hyogo College of Medicine
Institute
Department

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
URL(English) https://upload.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


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