UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023881 |
|---|---|
| Receipt number | R000027509 |
| Scientific Title | Change in eGFR after adminstration of tolvaptan and furosemide in liver cirrhosis patients with ascites:a randomized study |
| Date of disclosure of the study information | 2016/09/03 |
| Last modified on | 2019/10/15 23:40:44 |
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Basic information
Public title
Change in eGFR after adminstration of tolvaptan and furosemide in liver cirrhosis patients with ascites:a randomized study
Acronym
Change in eGFR after adminstration of tolvaptan and furosemide in liver cirrhosis patients
Scientific Title
Change in eGFR after adminstration of tolvaptan and furosemide in liver cirrhosis patients with ascites:a randomized study
Scientific Title:Acronym
Change in eGFR after adminstration of tolvaptan and furosemide in liver cirrhosis patients
Region
| Japan |
Condition
Condition
liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the influence of renal function afer an administration of tolvaptan and furosemide in liver cirrhosis patient with ascites.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in eGFR levels from baseline after adminstraion of diuretic for 24 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Change from the conventional diuretics to the tolvaptan
Interventions/Control_2
continuous administration of the conventional diuretics
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
1)Patients with liver cirrohsis with ascites in hepatic edema. Diagnosis of liver cirrhosis was based on laboratory results and imaging tests
2)Patients given oral furosemide 40-100mg/day and Spironolactone 25mg-200mg at the time of enrolling.
Key exclusion criteria
1)The anuric patients
2)Patients with urinary retention
3)Serum Na >=147mEq/L
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kinbara |
Organization
shonan kamakura general hospital
Division name
department of gastroenterology
Zip code
247-8533
Address
1370-1 okamoto,kamakura, kanagawa, japan
TEL
08043235412
kiruha555@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hyun Sung |
| Middle name | |
| Last name | Ji |
Organization
shonan kamakura general hospital
Division name
department of gastroenterology
Zip code
247-8533
Address
1370-1 okamoto,kamakura, kanagawa, japan
TEL
0467-46-1717
Homepage URL
sjh343434@yahoo.co.jp
Sponsor or person
Institute
shonan kamakura general hospital
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
Tokysyuukai
Address
1-8-7 Kojimachi, Chiyoda-ku, Tokyo
Tel
03-3263-4801
machida@mirai-iryo.com
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
湘南鎌倉総合病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 03 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027509
