Rifaximin Therapy in Chronic Kidney Disease

October 8, 2021 updated by: Jason Stubbs, MD

Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease

The purpose of this study is to determine if Rifaximin decreases serum and urine levels of bacterial byproducts and inflammatory markers in patients with chronic kidney disease and to evaluate changes in the bacterial content of the stool from these individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

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

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:

  • Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2

Exclusion Criteria:

  • Patients with normal renal function or those with less advanced kidney disease
  • Inability or unwillingness to provide consent
  • Patients undergoing hemodialysis or peritoneal dialysis therapy or those who have undergone organ transplant
  • 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, bile acid sequestrants and current or recent (within the last 3 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rifaximin
Participants will receive a 10-day course of Rifaximin.
Drug: Rifaximin
550mg pills
Other Names:
  • XIFAXAN®
Placebo Comparator: Placebo
Participants will receive a 10-day course of placebo.
Drug: Placebo
Placebo pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Serum Trimethylamine N-oxide (TMAO)
Time Frame: Change from baseline to Day 11
Change from baseline to Day 11

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive Protein
Time Frame: Change from baseline to Day 11
Change from baseline to Day 11
Change in Serum Interleukin-6 (IL-6)
Time Frame: Change from baseline to day 11
post- minus pre-treatment values
Change from baseline to day 11

Collaborators and Investigators

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

Sponsor

Jason Stubbs, MD

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2015

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 21, 2015

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001638

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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