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Rifaximin Therapy in Chronic Kidney Disease

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.
 
ClinicalTrials.gov Identifier: NCT02342639
Recruitment Status : Completed
First Posted : January 21, 2015
Results First Posted : November 5, 2021
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
Jason Stubbs, MD, University of Kansas Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Rifaximin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease
Study Start Date : June 2015
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Rifaximin
Participants will receive a 10-day course of Rifaximin.
Drug: Rifaximin
550mg pills
Other Name: XIFAXAN®

Placebo Comparator: Placebo
Participants will receive a 10-day course of placebo.
Drug: Placebo
Placebo pill




Primary Outcome Measures :
  1. Change in Serum Trimethylamine N-oxide (TMAO) [ Time Frame: Change from baseline to Day 11 ]

Secondary Outcome Measures :
  1. C-reactive Protein [ Time Frame: Change from baseline to Day 11 ]
  2. Change in Serum Interleukin-6 (IL-6) [ Time Frame: Change from baseline to day 11 ]
    post- minus pre-treatment values



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02342639


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Jason Stubbs, MD
Investigators
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Principal Investigator: Jason Stubbs, MD University of Kansas Medical Center
  Study Documents (Full-Text)

Documents provided by Jason Stubbs, MD, University of Kansas Medical Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jason Stubbs, MD, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02342639    
Other Study ID Numbers: STUDY00001638
First Posted: January 21, 2015    Key Record Dates
Results First Posted: November 5, 2021
Last Update Posted: November 5, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents