Rifaximin Versus Lactulose in Renal Failure

This study is currently recruiting participants.

Verified by Weill Medical College of Cornell University, September 2008

First Received: September 8, 2008 No Changes Posted

Sponsor:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00748904

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Kidney Failure

Drug Information available for: Rifaximin Lactulose

U.S. FDA Resources

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
A: Experimental 35 patients receiving rifaximin	Drug: Rifaximin 400 mg orally
B: Experimental 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

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:	Center for Liver Diseases and Transplantation ( Samuel Sigal )
Study ID Numbers:	0801009635
Study First Received:	September 8, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00748904 History of Changes
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:

Anti-Infective Agents
Liver Diseases
Renal Insufficiency
Fibrosis
Gastrointestinal Agents
Liver Cirrhosis
Pharmacologic Actions
Digestive System Diseases

Pathologic Processes
Urologic Diseases
Therapeutic Uses
Rifaximin
Kidney Diseases
Kidney Failure
Lactulose

ClinicalTrials.gov processed this record on February 08, 2010