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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027765
Receipt No. R000031821
Scientific Title Utility of resistance index (RI) measured with renal doppler ultrasonography to elucidate induction therapy of Tolvaptan
Date of disclosure of the study information 2017/06/20
Last modified on 2017/06/15

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Basic information
Public title Utility of resistance index (RI) measured with renal doppler ultrasonography to elucidate induction therapy of Tolvaptan
Acronym Effect of Tolvaptan using kidney resistance index
Scientific Title Utility of resistance index (RI) measured with renal doppler ultrasonography to elucidate induction therapy of Tolvaptan
Scientific Title:Acronym 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
1st name
Middle name
Last name Masahiro Kikuchi
Organization National Hospital Organization Tokyo Medical Center
Division name Department of Gastroenterology
Zip code
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
1st name
Middle name
Last name Masahiro Kikuchi
Organization National Hospital Organization Tokyo Medical Center
Division name Department of Gastroenterology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 04 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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