Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease

February 26, 2019 updated by: Jason Stubbs, MD
The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide (TMAO) levels in patients with end-stage renal disease.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Study participants will undergo 3 study visits: baseline, day 7 (immediately post-therapy), day 21 (2 weeks post-therapy). All participants will provide blood and stool samples at each visit.

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Westwood, Kansas, United States, 66205
        • Westwood Dialysis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of end-stage renal disease
  • Receiving chronic intermittent hemodialysis

Exclusion Criteria:

  • Patients with less advanced kidney disease
  • Inability or unwillingness to provide informed consent
  • Patients who may be pregnant
  • Hemodynamically unstable patients
  • Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease
  • Patients with ongoing or recent infection and those with history of C-diff infection
  • Patients with abnormal bowel structure secondary to surgical or anatomic variations
  • Patients on certain medications, including immunosuppressants, antidiarrheal agents, or recent (within the last 2 months) use of antibiotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rifaximin
Participants will receive study drug for a period of 7 days.
Drug: Rifaximin
One 550 mg tablet taken orally two times a day.
Other Names:
  • XIFAXAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum TMAO levels
Time Frame: Change from Baseline to Day 7
Change from Baseline to Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum TMAO levels
Time Frame: Change from Baseline to Day 21
Change from Baseline to Day 21
Change in fecal bacterial species
Time Frame: Change from Baseline to Day 7
Change from Baseline to Day 7
Change in fecal bacterial colony numbers
Time Frame: Change from Baseline to Day 7
Change from Baseline to Day 7
Change in fecal bacterial species
Time Frame: Change from Baseline to Day 21
Change from Baseline to Day 21
Change in fecal bacterial colony numbers
Time Frame: Change from Baseline to Day 21
Change from Baseline to Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jason Stubbs, MD

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Jason Stubbs, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

February 26, 2019

Study Completion (Actual)

February 26, 2019

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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