UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of the predictive factors for response to Tolvaptan in Liver cirrhosis patients with water retention
Title of the study (Brief title)	The study of the predictive factors for response to Tolvaptan in Liver cirrhosis patients with water retention
Region	Japan

Condition
Condition	Liver cirrhosis with refractory water retention
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the clinical effects of Tolvaptan and the predictive factors for response to Tolvaptan
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of urinary aquaporin-2 before and after the administration of Tolvaptan
Key secondary outcomes	The change of urinary osomolality, body weight,urinary volume before and after the administration of Tolvaptan

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	Liver cirrhosis patients with refractory water retention despite undergoing the other diuretics
Key exclusion criteria	(1)The patients with allergy to Tolvaptan (2)The patients who is difficult to take Tolvaptan (3)The patients who is difficult to drink water (4)The anuric patients (5)Hypernatremia (6)The pregnant
Target sample size	30

Research contact person
Name of lead principal investigator	Nakai Masato
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterology and hepatology
Address	Kita-15, Nishi-7 Kita-ku, Sapporo
TEL	0117161161
Email	mst-j45@med.hokudai.ac.jp

Public contact
Name of contact person	Masato Nakai
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterology and hepatology
Address	Kita-15, Nishi-7 Kita-ku, Sapporo
TEL	0117161161
Homepage URL
Email	mst-j45@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	北海道大学病院消化器内科

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 08 Day
Anticipated trial start date	2016 Year 01 Month 18 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded	2017 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Prospective observational study Liver cirrhosis patients who visit Hokkaido University Hospital until 2017/03/31

Management information
Registered date	2016 Year 03 Month 02 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024523