UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of resistance index (RI) measured with renal doppler ultrasonography to elucidate induction therapy of Tolvaptan
Title of the study (Brief title)	Effect of Tolvaptan using kidney resistance index
Region	Japan

Condition
Condition	liver cirrhosis with ascites
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	the clinical benefits of Tolvaptan with renal doppler ultrasonography
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	clinical benefits estimated 3 months later.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tolvaptan at 3.75mg/day was administered to cirrhotic patients with ascites unresponsive to standard diuretic therapy.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)a diagnosis of cirrhosis via laboratory data, imaging abnormalities, and the presence of a primary disease; (2) ascites caused by liver cirrhosis; and (3) unresponsive to standard diuretics such as furosemide and spironolactone.
Key exclusion criteria	(1) active gastrointestinal bleeding, (2) overt hepatic encephalopathy, (3) spontaneous bacterial peritonitis, (4) heart failure and stage 4 chronic kidney disease.
Target sample size	15

Research contact person
Name of lead principal investigator	Masahiro Kikuchi
Organization	National Hospital Organization Tokyo Medical Center
Division name	Department of Gastroenterology
Address	2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8902 Japan.
TEL	+81-3-3411-0111
Email	kikuchim490611@yahoo.co.jp

Public contact
Name of contact person	Masahiro Kikuchi
Organization	National Hospital Organization Tokyo Medical Center
Division name	Department of Gastroenterology
Address	2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8902 Japan
TEL	+81-3-3411-0111
Homepage URL
Email	kikuchim490611@yahoo.co.jp

Sponsor
Institute	National Hospital Organization Tokyo Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Tokyo Medical Center
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 15 Day
Last modified on	2017 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031821