Rifaximin Versus Lactulose in Renal Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00748904
First received: September 8, 2008
Last updated: January 3, 2011
Last verified: January 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Samuel Sigal, Center for Liver Diseases and Transplantation
ClinicalTrials.gov Identifier: NCT00748904     History of Changes
Other Study ID Numbers: 0801009635
Study First Received: September 8, 2008
Last Updated: January 3, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Renal Insufficiency
Liver Diseases
Digestive System Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Rifaximin
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 29, 2014