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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023881
Receipt No. 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 2018/01/31

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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
Middle name
Last name Kinbara Takeshi
Organization shonan kamakura general hospital
Division name department of gastroenterology
Zip code
Address 1370-1 okamoto,kamakura, kanagawa, japan
TEL 0467-46-1717
Email t_kinbara@shonankamakura.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ji Hyun Sung
Organization shonan kamakura general hospital
Division name department of gastroenterology
Zip code
Address 1370-1 okamoto,kamakura, kanagawa, japan
TEL 0467-46-1717
Homepage URL
Email sjh343434@yahoo.co.jp

Sponsor
Institute shonan kamakura general hospital
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
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
2018 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027509

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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