UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027765 |
|---|---|
| Receipt number | 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 12:59:57 |
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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
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
kikuchim490611@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031821
