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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036201
Receipt No. R000041238
Scientific Title Analysis of relation between itraconazole blood concentration and body clinical dynamics,laboratory test values
Date of disclosure of the study information 2019/03/14
Last modified on 2019/03/14

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Basic information
Public title Analysis of relation between itraconazole blood concentration and body clinical dynamics,laboratory test values
Acronym Analysis of relation between itraconazole blood concentration and body clinical dynamics,laboratory test values
Scientific Title Analysis of relation between itraconazole blood concentration and body clinical dynamics,laboratory test values
Scientific Title:Acronym Analysis of relation between itraconazole blood concentration and body clinical dynamics,laboratory test values
Region
Japan

Condition
Condition Immunocompromised patients
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 In this study, itraconazole and its metabolites (OH - ITZ), keto form (keto - ITZ), dealkylated form (ND - ITZ)) were measured in patients with compromised infection. To clarify the relationship between the blood concentration of ITZ and clinical laboratory values, and to establish a prediction method of blood kinetics.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) The total blood concentration and free form blood concentration (including optical isomers) of ITZ and its metabolites (OH - ITZ, Keto - ITZ, ND - ITZ)2) Free form fraction of ITZ and its metabolites
3) Blood kinetics Parameter fluctuation factors (clinical laboratory values, glycoalbumin, diseases, concomitant medications, inflammatory markers, liver and kidney function markers)
Study 1: Relationship between blood concentration and liver function marker (concentration of CYP3A active marker (4B hydroxylated cholesterol in the blood, 25 hydroxylated vitamin D3 in blood, miRNA-24b), drug metabolizing enzymes (CYP3A4, CYP3A5) Genetic polymorphism of drug transport carriers (OATP 1 B 1, OATP 1 B 3, ABCB 1, ABCC 2, ABCG 2, MATE 1, MATE 2), total bilirubin, coproporphyrin etc.)
Study 2: Relationship between blood concentration and kidney function marker (creatinine, cystatin C, BUN, etc.)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who is over 20 years old and has been taking at least 14 days after starting taking itraconazole
2) Patients who judged that doctor can participate in this research
3) Patients who was able to obtain consent by signing the consent form by the person himself / herself to participate in this research
4) Patients who gained consent by consent form regarding use of the sample or information for research
Key exclusion criteria exclusion criteria: (1) patients who were being co-treated with a strong inducer or inhibitor of CYPs, including macrolide antibiotics, rifampicin, and carbamazepine (2) patients who were receiving administration of cyclosporin A; (3) patients who were receiving ITZ oral solution except for before bedtime; (4) patients who were being co-treated with more than 1 g per day of sulfamethoxazole (5) patients who had severe bacterial or mycotic infections; (6) patients with hepatic dysfunction (serum total bilirubin > 2.0 mg/dL) before starting ITZ; (7) patients with more than 1.5 mg/dL of serum creatinine before staring ITZ; and (8) patients with poor adherence based on pharmacist interviews and medical records; (9) patients who judged that doctor is inappropriate ; (10) patients who did not obtain consent to participate in this research
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Junichi
Middle name
Last name Kawakami
Organization Hamamatsu University School of Medicine
Division name Department of Hospital Pharmacy
Zip code 4313192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL 0534352763
Email kawakami-ham@umin.ac.jpp

Public contact
Name of contact person
1st name Yumi
Middle name
Last name Imoto
Organization Hamamatsu University School of Medicine
Division name Department of Hospital Pharmacy
Zip code 4313192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL 0534352763
Homepage URL
Email yimoto@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine Department of Hospital Pharmacy
Institute
Department

Funding Source
Organization Self-procurement
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Hamamatsu University Hospital
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
Tel 0534352850
Email maiko615@hama-med.ac.jp

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
2019 Year 03 Month 14 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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 27 Day
Date of IRB
2017 Year 03 Month 06 Day
Anticipated trial start date
2017 Year 03 Month 06 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 03 Month 14 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041238

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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