UMIN-CTR Clinical Trial

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