UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036201 |
|---|---|
| Receipt number | 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 | 2021/09/13 16:41:23 |
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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
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
yimoto@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine Department of Hospital Pharmacy
Institute
Department
Personal name
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
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
| 2025 | 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
| 2021 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041238
