UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021300 |
|---|---|
| Receipt number | R000024523 |
| Scientific Title | The study of the predictive factors for response to Tolvaptan in Liver cirrhosis patients with water retention |
| Date of disclosure of the study information | 2016/03/03 |
| Last modified on | 2018/09/20 19:49:20 |
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Basic information
Public title
The study of the predictive factors for response to Tolvaptan in Liver cirrhosis patients with water retention
Acronym
The study of the predictive factors for response to Tolvaptan in Liver cirrhosis patients with water retention
Scientific Title
The study of the predictive factors for response to Tolvaptan in Liver cirrhosis patients with water retention
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Nakai Masato |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterology and hepatology
Zip code
Address
Kita-15, Nishi-7 Kita-ku, Sapporo
TEL
0117161161
mst-j45@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Nakai |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterology and hepatology
Zip code
Address
Kita-15, Nishi-7 Kita-ku, Sapporo
TEL
0117161161
Homepage URL
mst-j45@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 08 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024523
