Back to resultsRifaximin Versus Lactulose in Renal Failure
Primary Purpose
Liver Cirrhosis, Renal Failure
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
Lactulose
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring cirrhosis of liver and progressive renal failure
Eligibility Criteria
Inclusion Criteria:
- cirrhosis of liver of any etiology
- progressive renal failure
- stage 0-2 hepatic encephalopathy
Exclusion Criteria:
- pregnant women
Sites / Locations
- Weill Cornell Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
35 patients receiving rifaximin
35 patients receiving lactulose
Outcomes
Primary Outcome Measures
slower progression to severe hepatic encephalopathy, stage 3 or 4
Secondary Outcome Measures
Full Information
NCT ID
NCT00748904
First Posted
September 8, 2008
Last Updated
January 24, 2022
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT00748904
Brief Title
Rifaximin Versus Lactulose in Renal Failure
Official Title
A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate patients with cirrhosis of the liver and renal failure and determine if the administration of rifaximin as compared to lactulose is associated with less frequent and/or slower progression to severe hepatic encephalopathy. If one is associated with lower blood ammonia levels. And, if one is associated with lower breath hydrogen and methane levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Renal Failure
Keywords
cirrhosis of liver and progressive renal failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
35 patients receiving rifaximin
Arm Title
B
Arm Type
Experimental
Arm Description
35 patients receiving lactulose
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Xifaxin, Salix Pharmaceuticals
Intervention Description
400 mg orally
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
20 grams titrate to 2-3 bowel movements in one day
Primary Outcome Measure Information:
Title
slower progression to severe hepatic encephalopathy, stage 3 or 4
Time Frame
during hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cirrhosis of liver of any etiology
progressive renal failure
stage 0-2 hepatic encephalopathy
Exclusion Criteria:
pregnant women
Facility Information:
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
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Rifaximin Versus Lactulose in Renal Failure
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