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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038487
Receipt No. R000043845
Scientific Title USE OF RIFAXIMIN THERAPY IN PRIMARY PREVENTION OF HEPATORENAL SYNDROME IN CIRRHOTIC PATIENTS WITH ASCITES
Date of disclosure of the study information 2019/11/03
Last modified on 2019/11/03

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Basic information
Public title USE OF RIFAXIMIN THERAPY IN PRIMARY PREVENTION OF HEPATORENAL SYNDROME IN CIRRHOTIC PATIENTS WITH ASCITES
Acronym USE OF RIFAXIMIN THERAPY IN PRIMARY PREVENTION OF HEPATORENAL SYNDROME IN CIRRHOTIC PATIENTS WITH ASCITES
Scientific Title USE OF RIFAXIMIN THERAPY IN PRIMARY PREVENTION OF HEPATORENAL SYNDROME IN CIRRHOTIC PATIENTS WITH ASCITES
Scientific Title:Acronym USE OF RIFAXIMIN THERAPY IN PRIMARY PREVENTION OF HEPATORENAL SYNDROME IN CIRRHOTIC PATIENTS WITH ASCITES
Region
Asia(except Japan)

Condition
Condition Liver Cirrhosis with ascites
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Nephrology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To see incidence of Hepatorenal syndrome in rifaximin group vs control group.
Basic objectives2 Others
Basic objectives -Others To see renal function test (i.e. urea and creatinine ) in rifaxamin group and control group
at baseline , 4 week, 8 week & 12 week.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence of hepatorenal syndrome within 12 weeks.
Key secondary outcomes Change in urea and creatinine level at 4 week,8week and 12 week.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Rifaximin group ,Tab rifaximin at a dose of 550mg BD for 12 weeks and other
standard treatment.

Interventions/Control_2 Non Rifaximin group,Only standar Rx.
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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Age of the patients to be above 18 yrs .
2.Diagnosis of liver cirrhosis and documented ascites.
3.Child-Pugh score of 7 or more
Key exclusion criteria 1. Patients with renal impairment (serum creatinine>1.5mg/dl)
2. History of HRS, nephropathy and obstructive Uropathy
3. Recent exposure to radioactive materials and Nephrotoxic drugs
4. Sepsis
5. Hepatocellular carcinoma
6. History of allergic reaction with rifaxmin.
Target sample size 94

Research contact person
Name of lead principal investigator
1st name Sanjit
Middle name
Last name Karki
Organization Patan Academy of health sciences,Patan Hospital.
Division name Medicine,Gastroenterology
Zip code 44600
Address .Lagankhel,lalitpur,Nepal
TEL 9841277196
Email sanjitkarki@pahs.edu.np

Public contact
Name of contact person
1st name Sanjit
Middle name
Last name Karki
Organization Patan Academy of Health sciences
Division name Medicine,Gastrenterology
Zip code 44600
Address Lagankhel,lalitpur,Nepal
TEL 9841277196
Homepage URL
Email sanjitkarki@pahs.edu.np

Sponsor
Institute NationalAcademy of health Sciences,Bir Hospital
Department Of Medicine
Gastroenterology Unit
Institute
Department

Funding Source
Organization NationalAcademy of health Sciences,Bir Hospital
Department Of Medicine
Gastroenterology Unit
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 National Academy of medical sciences
Address Mahaboudha,Kathmandu,Nepal
Tel +977-1-4230710
Email admin@nams.org.np

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
2019 Year 11 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
2019 Year 01 Month 02 Day
Date of IRB
2019 Year 03 Month 12 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2020 Year 03 Month 30 Day
Date of closure to data entry
2020 Year 03 Month 30 Day
Date trial data considered complete
2020 Year 06 Month 15 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 03 Day
Last modified on
2019 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043845

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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