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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

Tracking Information
First Submitted Date  ICMJE January 15, 2015
First Posted Date  ICMJE January 21, 2015
Results First Submitted Date  ICMJE September 15, 2021
Results First Posted Date  ICMJE November 5, 2021
Last Update Posted Date November 5, 2021
Study Start Date  ICMJE June 2015
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2021)
Change in Serum Trimethylamine N-oxide (TMAO) [ Time Frame: Change from baseline to Day 11 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
Change in serum TMAO [ Time Frame: Change from baseline to Day 11 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2021)
  • C-reactive Protein [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
  • Change in urine TMAO [ Time Frame: Change from baseline to Day 11 ]
  • Change in serum levels of inflammatory cytokines [ Time Frame: Change from baseline to Day 11 ]
  • Measure in alteration of bowel microbiota [ Time Frame: Change from baseline to Day 11 ]
  • Change in serum bacterial endotoxin levels [ Time Frame: Change from baseline to Day 11 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rifaximin Therapy in Chronic Kidney Disease
Official Title  ICMJE Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Rifaximin
    550mg pills
    Other Name: XIFAXAN®
  • Drug: Placebo
    Placebo pill
Study Arms  ICMJE
  • Experimental: Rifaximin
    Participants will receive a 10-day course of Rifaximin.
    Intervention: Drug: Rifaximin
  • Placebo Comparator: Placebo
    Participants will receive a 10-day course of placebo.
    Intervention: Drug: Placebo
Publications * Kimber C, Zhang S, Johnson C, West RE 3rd, Prokopienko AJ, Mahnken JD, Yu AS, Hoofnagle AN, Ir D, Robertson CE, Miyazaki M, Chonchol M, Jovanovich A, Kestenbaum B, Frank DN, Nolin TD, Stubbs JR. Randomized, Placebo-Controlled Trial of Rifaximin Therapy for Lowering Gut-Derived Cardiovascular Toxins and Inflammation in CKD. Kidney360. 2020 Nov;1(11):1206-1216. doi: 10.34067/kid.0003942020. Epub 2020 Nov 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2021)
38
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2015)
30
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02342639
Other Study ID Numbers  ICMJE STUDY00001638
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jason Stubbs, MD, University of Kansas Medical Center
Study Sponsor  ICMJE Jason Stubbs, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason Stubbs, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP