UMIN-CTR Clinical Trial

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

Hematologic diseases

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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 ≥5.0 x Upper Limit of Normal(ULN)
2. Bilirubin ≥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

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

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

Institute

Cellular transplantation biology,
Graduate School of Medical Science, Kanazawa University

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

02

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

02

Month

23

Day

Last modified on

2010

Year

02

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003920