UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033065
Receipt number 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 22:03:48

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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 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

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

Value
https://center6.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