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Rifaximin Versus Lactulose in Renal Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Weill Medical College of Cornell University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00748904
First Posted: September 9, 2008
Last Update Posted: January 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Weill Medical College of Cornell University
  Purpose
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.

Condition Intervention Phase
Liver Cirrhosis Renal Failure Drug: Rifaximin Drug: Lactulose Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • slower progression to severe hepatic encephalopathy, stage 3 or 4 [ Time Frame: during hospitalization ]

Estimated Enrollment: 70
Study Start Date: June 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
35 patients receiving rifaximin
Drug: Rifaximin
400 mg orally
Other Name: Xifaxin, Salix Pharmaceuticals
Experimental: B
35 patients receiving lactulose
Drug: Lactulose
20 grams titrate to 2-3 bowel movements in one day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cirrhosis of liver of any etiology
  • progressive renal failure
  • stage 0-2 hepatic encephalopathy

Exclusion Criteria:

  • pregnant women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748904


Contacts
Contact: Samuel Sigal, MD 212-746-4129 shs2015@nyp.org
Contact: Amy Tilara, MD 646-713-7284 amy.tilara@gmail.com

Locations
United States, New York
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10021
Contact: Samuel Sigal, MD    212-746-4129    shs2015@nyp.org   
Contact: Amy Tilara, MD    646-713-7284    amy.tilara@gmail.com   
Principal Investigator: Samuel Sigal, MD         
Sub-Investigator: Amy Tilara, MD         
Sub-Investigator: Ilan Weisberg, MD         
Sub-Investigator: Melanie Starcic, PA         
Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

Responsible Party: Samuel Sigal, Center for Liver Diseases and Transplantation
ClinicalTrials.gov Identifier: NCT00748904     History of Changes
Other Study ID Numbers: 0801009635
First Submitted: September 8, 2008
First Posted: September 9, 2008
Last Update Posted: January 4, 2011
Last Verified: January 2011

Keywords provided by Weill Medical College of Cornell University:
cirrhosis of liver and progressive renal failure

Additional relevant MeSH terms:
Fibrosis
Renal Insufficiency
Liver Cirrhosis
Pathologic Processes
Kidney Diseases
Urologic Diseases
Liver Diseases
Digestive System Diseases
Rifaximin
Rifamycins
Lactulose
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents