UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038304
Receipt number R000043657
Scientific Title Change in diuretic dose after administration of Tolvaptan in liver cirrhosis patients with ascites
Date of disclosure of the study information 2019/10/20
Last modified on 2021/07/20 20:03:34

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Basic information

Public title

Change in diuretic dose after administration of Tolvaptan in liver cirrhosis patients with ascites

Acronym

Change in diuretic dose in liver cirrhosis patients with ascites

Scientific Title

Change in diuretic dose after administration of Tolvaptan in liver cirrhosis patients with ascites

Scientific Title:Acronym

Change in diuretic dose in liver cirrhosis patients with ascites

Region

Japan


Condition

Condition

liver cirrhosis

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the rate of patients with dose reduction of diuretic after an administration of tolvaptan in liver cirrhosis patient with ascites.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To assess the rate of patients who attain furosemide free and tolvaptan free.

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 with liver cirrohsis with ascites in hepatic edema. Diagnosis of liver cirrhosis was based on laboratory results and imaging tests
2)Patients given oral furosemide 40-100mg/day and Spironolactone 25mg-200mg at the time of enrolling.

Key exclusion criteria

1)The anuric patients
2)Patients with urinary retention
3)Serum Na >=147mEq/L

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Haruki
Middle name
Last name Uojima

Organization

Kitasato University school of medicine

Division name

Department of Gastroenterology

Zip code

252-0374

Address

1-15-1 Kitasato Minami Sagamihara Kanagawa Japan

TEL

+81-42-778-8111

Email

kiruha555@yahoo.co.jp


Public contact

Name of contact person

1st name Haruki
Middle name
Last name Uojima

Organization

Kitasato University school of medicine

Division name

Department of Gastroenterology

Zip code

252-0374

Address

1-15-1 Kitasato Minami Sagamihara Kanagawa Japan

TEL

+81-42-778-8111

Homepage URL


Email

kiruha555@yahoo.co.jp


Sponsor or person

Institute

Kitasato University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kitasato 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

Kitasato University School of Medicine Independent Ethics Committee.

Address

1-15-1 Kitasato Minami Sagamihara Kanagawa Japan

Tel

+81-42-778-8111

Email

rinrib@med.kitasato-u.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 10 Month 20 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

Open public recruiting

Date of protocol fixation

2019 Year 06 Month 01 Day

Date of IRB

2019 Year 06 Month 01 Day

Anticipated trial start date

2019 Year 10 Month 20 Day

Last follow-up date

2023 Year 10 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Unpublished


Management information

Registered date

2019 Year 10 Month 16 Day

Last modified on

2021 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043657


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name