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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Chronic Kidney Disease
Interventions Drug: Rifaximin
Drug: Placebo
Enrollment 38
Recruitment Details Recruitment period: June 2015 - January 2017
Pre-assignment Details  
Arm/Group Title Rifaximin Placebo
Hide Arm/Group Description

Participants will receive a 10-day course of Rifaximin 550mg PO BID.

Rifaximin: 550mg pills

Participants will receive a 10-day course of placebo PO BID.

Placebo: Placebo pill

Period Title: Overall Study
Started 19 19
Completed 17 14
Not Completed 2 5
Reason Not Completed
Acute illness, unrelated to study drug             2             3
Protocol Violation             0             2
Arm/Group Title Rifaximin Placebo Total
Hide Arm/Group Description

Participants will receive a 10-day course of Rifaximin.

Rifaximin: 550mg PO BID

Participants will receive a 10-day course of placebo.

Placebo: Placebo PO BID

Total of all reporting groups
Overall Number of Baseline Participants 17 14 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 14 participants 31 participants
62  (13) 65  (9) 64  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
Female
6
  35.3%
8
  57.1%
14
  45.2%
Male
11
  64.7%
6
  42.9%
17
  54.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  17.6%
3
  21.4%
6
  19.4%
White
14
  82.4%
9
  64.3%
23
  74.2%
More than one race
0
   0.0%
2
  14.3%
2
   6.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 17 participants 14 participants 31 participants
31  (8) 35  (9) 33  (8)
Diagnosis of diabetes   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
7
  41.2%
11
  78.6%
18
  58.1%
[1]
Measure Description: Patients with a known diagnosis of diabetes mellitus
Chronic kidney disease etiology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
Diabetes
4
  23.5%
10
  71.4%
14
  45.2%
Glomerulonephritis
1
   5.9%
0
   0.0%
1
   3.2%
Hypertension
4
  23.5%
1
   7.1%
5
  16.1%
Polycystic kidney disease
0
   0.0%
1
   7.1%
1
   3.2%
Other/unknown
8
  47.1%
2
  14.3%
10
  32.3%
Estimated glomerular filtration rate  
Mean (Standard Deviation)
Unit of measure:  Ml/min/1.73m^2
Number Analyzed 17 participants 14 participants 31 participants
27.9  (10.6) 34.4  (14.2) 30.8  (12.6)
Serum Trimethylamine N-oxide  
Mean (Standard Deviation)
Unit of measure:  uM
Number Analyzed 17 participants 14 participants 31 participants
18.8  (18.7) 15.6  (11.6) 17.3  (15.7)
Serum P-cresol sulfate  
Mean (Standard Deviation)
Unit of measure:  Ug/ml
Number Analyzed 17 participants 14 participants 31 participants
18.5  (10.0) 14.4  (4.7) 16.7  (8.2)
Serum indoxyl sulfate  
Mean (Standard Deviation)
Unit of measure:  Ug/ml
Number Analyzed 17 participants 14 participants 31 participants
3.7  (2.0) 2.3  (0.8) 3.1  (1.8)
Serum kynurenic acid  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 17 participants 14 participants 31 participants
28.1  (21.3) 19.6  (19.0) 24.3  (16.8)
Serum deoxycholic acid  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 17 participants 14 participants 31 participants
372.2  (268.3) 609.8  (384.7) 479.5  (342.0)
Serum C-reactive protein  
Mean (Standard Deviation)
Unit of measure:  Ug/ml
Number Analyzed 17 participants 14 participants 31 participants
8.5  (22.1) 8.2  (11.6) 8.4  (17.9)
Serum Interleukin-6  
Mean (Standard Deviation)
Unit of measure:  Pg/ml
Number Analyzed 17 participants 14 participants 31 participants
2.1  (1.6) 3.3  (2.6) 2.7  (2.2)
Severity of Proteinuria  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
None
6
  35.3%
6
  42.9%
12
  38.7%
Mild
4
  23.5%
4
  28.6%
8
  25.8%
Moderate
7
  41.2%
4
  28.6%
11
  35.5%
1.Primary Outcome
Title Change in Serum Trimethylamine N-oxide (TMAO)
Hide Description [Not Specified]
Time Frame Change from baseline to Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rifaximin Placebo
Hide Arm/Group Description:

Participants will receive a 10-day course of Rifaximin.

Rifaximin: 550mg pills

Participants will receive a 10-day course of placebo.

Placebo: Placebo pill

Overall Number of Participants Analyzed 17 14
Mean (Standard Deviation)
Unit of Measure: uM
-3.9  (15.4) 0.5  (9.5)
2.Secondary Outcome
Title C-reactive Protein
Hide Description [Not Specified]
Time Frame Change from baseline to Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rifaximin Placebo
Hide Arm/Group Description:

Participants will receive a 10-day course of Rifaximin 550mg PO BID.

Rifaximin: 550mg pills

Participants will receive a 10-day course of placebo PO BID.

Placebo: Placebo pill

Overall Number of Participants Analyzed 17 14
Mean (Standard Deviation)
Unit of Measure: ug/ml
6.0  (19.7) -2.6  (5.8)
3.Secondary Outcome
Title Change in Serum Interleukin-6 (IL-6)
Hide Description post- minus pre-treatment values
Time Frame Change from baseline to day 11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rifaximin Placebo
Hide Arm/Group Description:

Participants will receive a 10-day course of Rifaximin.

Rifaximin: 550mg pills

Participants will receive a 10-day course of placebo.

Placebo: Placebo pill

Overall Number of Participants Analyzed 17 14
Mean (Standard Deviation)
Unit of Measure: pg/ml
0.3  (1.1) 0.8  (2.1)
Time Frame 11 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rifaximin Placebo
Hide Arm/Group Description

Participants will receive a 10-day course of Rifaximin 550mg PO BID.

Rifaximin: 550mg pills

Participants will receive a 10-day course of placebo PO BID.

Placebo: Placebo pill

All-Cause Mortality
Rifaximin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)      0/14 (0.00%)    
Hide Serious Adverse Events
Rifaximin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rifaximin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      2/14 (14.29%)    
Gastrointestinal disorders     
Cramping/diarrhea   0/17 (0.00%)  0 2/14 (14.29%)  2
bleeding  [1]  1/17 (5.88%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
GI bleeding - supra-therapeutic INR
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jason Stubbs
Organization: University of Kansas Medical Center
Phone: 9135886074
EMail: jstubbs@kumc.edu
Layout table for additonal information
Responsible Party: Jason Stubbs, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02342639    
Other Study ID Numbers: STUDY00001638
First Submitted: January 15, 2015
First Posted: January 21, 2015
Results First Submitted: September 15, 2021
Results First Posted: November 5, 2021
Last Update Posted: November 5, 2021