Rifaximin Therapy in Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rifaximin
Placebo
Arm Description
Participants will receive a 10-day course of Rifaximin.
Participants will receive a 10-day course of placebo.
Outcomes
Primary Outcome Measures
Change in Serum Trimethylamine N-oxide (TMAO)
Secondary Outcome Measures
C-reactive Protein
Change in Serum Interleukin-6 (IL-6)
post- minus pre-treatment values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02342639
Brief Title
Rifaximin Therapy in Chronic Kidney Disease
Official Title
Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Stubbs, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rifaximin
Arm Type
Experimental
Arm Description
Participants will receive a 10-day course of Rifaximin.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a 10-day course of placebo.
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
XIFAXAN®
Intervention Description
550mg pills
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pill
Primary Outcome Measure Information:
Title
Change in Serum Trimethylamine N-oxide (TMAO)
Time Frame
Change from baseline to Day 11
Secondary Outcome Measure Information:
Title
C-reactive Protein
Time Frame
Change from baseline to Day 11
Title
Change in Serum Interleukin-6 (IL-6)
Description
post- minus pre-treatment values
Time Frame
Change from baseline to day 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Stubbs, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34322673
Citation
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.
Results Reference
derived
Learn more about this trial
Rifaximin Therapy in Chronic Kidney Disease
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