UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041334 |
|---|---|
| Receipt number | R000047199 |
| Scientific Title | Evaluation of blood biomarkers related to interindividual difference in pharmacokinetics and clinical effects of tolvaptan enantiomers and their metabolites in heart failure patients |
| Date of disclosure of the study information | 2020/08/31 |
| Last modified on | 2020/08/06 16:20:42 |
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Basic information
Public title
Evaluation of blood biomarkers related to interindividual difference in pharmacokinetics and clinical effects of tolvaptan enantiomers and their metabolites in heart failure patients
Acronym
Evaluation of blood biomarkers related to interindividual difference in pharmacokinetics and clinical effects of tolvaptan enantiomers and their metabolites in heart failure patients
Scientific Title
Evaluation of blood biomarkers related to interindividual difference in pharmacokinetics and clinical effects of tolvaptan enantiomers and their metabolites in heart failure patients
Scientific Title:Acronym
Evaluation of blood biomarkers related to interindividual difference in pharmacokinetics and clinical effects of tolvaptan enantiomers and their metabolites in heart failure patients
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study evaluates the interindividual variabilities of plasma dispositions of tolvaptan enantiomers and their metabolites determined by LC-MS/MS and clinical responses and adverse effects by investigating the patient background, plasma concentrations of biomarkers related to tolvaptan metabolism, and genetic variants of relevant enzymes and tranporters.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentrations of tolvaptan enantiomers and their metabolites just before dosing on the 7th day after starting medication or later.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients treated with tolvaptan for heart failures or cirrhosis
2. Patients receiving written informed consent
Key exclusion criteria
1. Patients discontinuing tolvaptan
2. Patients who are judged by physicians as inappropriate for study enrollment
Target sample size
200
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, Hamamatsu 431-3192
TEL
053-435-2763
pharmacyham-adm@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Hoshikawa |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital pharmacy
Zip code
4313192
Address
1-20-1 Handayama, Hamamatsu 431-3192
TEL
053-435-2763
Homepage URL
pharmacyham-adm@umin.ac.jp
Sponsor or person
Institute
Department of Hospital pharmacy
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hospital pharmacy
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Hamamatsu 431-3192
Tel
053-435-2680
rinri@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
| 2020 | Year | 08 | Month | 31 | 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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Observational study
Primary outcome: Plasma concentrations of tolvaptan enantiomers and their metabolites(DM4103, DM-4104, DM-4105, DM4107, DM4110, DM4111, DM4119, MOP21826) just before dosing on the 7th day after starting medication or later.
Secondary outcome:
1. Plasma 4beta-hydroxycholesterol
2. Plasma miRNAs
3. Plasma 25-hydroxy vitamin D
4. Polymorphisms of CYP3A4, CYP3A5, and ketone reductase
5. Polymorphisms of ABCB1
6. Polymorphisms of AVPR2
7. Patient status data(Child-Pugh score etc.)
8. Therapeutic efficacy(body weight change, water balance)
9. Patient background data(sex, age, weight etc.)
10. Laboratory values
11. Concomitant drugs
12. Comprehensive quantification of miRNAs in blood for an exploratory analysis
13. Plasma coproporphyrin I, III
Management information
Registered date
| 2020 | Year | 08 | Month | 06 | Day |
Last modified on
| 2020 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047199
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
