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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003240
Receipt No. R000003920
Scientific Title Study to test influence of itraconazole on blood level of cyclosporine and tacrolimus in patients after allogeneic stem cell transplantation
Date of disclosure of the study information 2010/02/23
Last modified on 2010/02/23

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Basic information
Public title Study to test influence of itraconazole on blood level of cyclosporine and tacrolimus in patients after allogeneic stem cell transplantation
Acronym Influence of itraconazole on blood level of cyclosporine/tacrolimus after allo-SCT
Scientific Title Study to test influence of itraconazole on blood level of cyclosporine and tacrolimus in patients after allogeneic stem cell transplantation
Scientific Title:Acronym Influence of itraconazole on blood level of cyclosporine/tacrolimus after allo-SCT
Region
Japan

Condition
Condition Hematologic diseases
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We prospectively examine the influence of itraconazole (ITCZ) on blood level of cyclosporine (CyA) and tacrolimus (TAC) in patients after allogeneic stem cell transplantation (HSCT)

Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Create a calculating formula to predict the blood level of CyA or TAC and concentration-to-dose (C/D) ratio combined with ITCZ administration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Itrizole oral solution, 20ml at 11AM or Itrizole injection, 200mg at 11-12AM single daily dosing, are administered for ITCZ. Sandimmun injection , 20ml at 11AM or Itrizole injection, 200mg at 11-12AM single daily dosing, are given to achieve the target trough level: 10ng/ml for ITCZ. Prograf injection, continuous intravenous drip or Prograf Capsule, 8AM and 8PM are given to achieve the target trough level: 10ng/ml are given for TAC.
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meets all of 3 criteria as follows;
1. Patients with hematologic disease who will be treated with allogeneic hematopoietic stem cell transplantation (HSCT) and scheduled to be given CyA or TAC.
2. Patients who are treated, or who are planned to treat with ITCZ.
3. Written informed consent are obtained.
Key exclusion criteria Patients who meets one (or more) of each criteria as follows;
1. AST/ALT &#8805;5.0 x Upper Limit of Normal(ULN)
2. Bilirubin &#8805;2 mg/dl
3. Hypersensitivity for ITCZ
4. Glomerular filtration rate <30 ml/min
5. Use of contraindicated drug to ITCZ
6. Be disqualified by attending physician
Target sample size 23

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name ISHIYAMA, Ken
Organization Graduate School of Medical Science,
Kanazawa University
Division name Cellular transplantation biology
Zip code
Address 13-1, Takaramachi, Kanazawa, Ishikawa, Japan
TEL 076-265-2000
Email

Public contact
Name of contact person
1st name
Middle name
Last name ISHIYAMA, Ken
Organization Graduate School of Medical Science, Kanazawa University
Division name Cellular transplantation biology
Zip code
Address 13-1, Takaramachi, Kanazawa, Ishikawa, Japan
TEL 076-265-2000
Homepage URL http://www.3nai.jp/service/index.html
Email ishiyamak@med3.m.kanazawa-u.ac.jp

Sponsor
Institute Cellular transplantation biology,
Graduate School of Medical Science, Kanazawa University
Institute
Department

Funding Source
Organization Clinical Drug Informatics, Graduate School of Pharmaceutical Science, and Cellular transplantation biology,
Graduate School of Medical Science, Kanazawa University
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 02 Month 23 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 07 Month 08 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 23 Day
Last modified on
2010 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003920

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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