UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033065
Receipt No. R000037702
Scientific Title Analysis on individual difference in pharmacokinetics of tolvaptan and its metabolites, and investigation on predictive parameters of tolvaptan response and adverse effects in Japanese patiens
Date of disclosure of the study information 2018/06/21
Last modified on 2019/06/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Analysis on individual difference in pharmacokinetics of tolvaptan and its metabolites, and investigation on predictive parameters of tolvaptan response and adverse effects in Japanese patiens
Acronym Analysis on individual difference in pharmacokinetics of tolvaptan and its metabolites, and investigation on predictive parameters of tolvaptan response and adverse effects in Japanese patiens
Scientific Title Analysis on individual difference in pharmacokinetics of tolvaptan and its metabolites, and investigation on predictive parameters of tolvaptan response and adverse effects in Japanese patiens
Scientific Title:Acronym Analysis on individual difference in pharmacokinetics of tolvaptan and its metabolites, and investigation on predictive parameters of tolvaptan response and adverse effects in Japanese patiens
Region
Japan

Condition
Condition heart failures, cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine Cardiology Vascular surgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This study evaluate the interindividual variabilities of plasma dispositions of tolvaptan and its metabolites determined by LC-MS/MS and clinical responses and adverse effects by investigating the patient background, plasma concentrations of proteins related with tolvaptan metabolism, and genetic variants of cytochrome P450.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma concentrations of tolvaptan and its 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
Email pharmacyham-adm@umin.ac.jp

Public contact
Name of contact person
1st name Takafumi
Middle name
Last name Naito
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
Email pharmacyham-adm@umin.ac.jp

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

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
Email 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 浜松医科大学医学部付属病院(静岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 21 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 06 Month 01 Day
Date of IRB
2017 Year 05 Month 17 Day
Anticipated trial start date
2017 Year 06 Month 08 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Observational study
Object recruitment: All patients who visit our hospital and meet the selection criteria from June 2017 to May 2022
Primary outcome: Plasma concentrations of tolvaptan and its metabolites(DM4103, 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 miRNA-27b
3. Plasma 25-hydroxy vitamin D
4. Polymorphisms of CYP3A4 and CYP3A5
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

Management information
Registered date
2018 Year 06 Month 20 Day
Last modified on
2019 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037702

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.