UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000037702