Trial Outcomes & Findings for Rifaximin Therapy in Chronic Kidney Disease (NCT NCT02342639)

NCT ID: NCT02342639

Last Updated: 2021-11-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 38 participants
• Primary outcome timeframe: Change from baseline to Day 11
• Results posted on: 2021-11-05

Participant Flow

Recruitment period: June 2015 - January 2017

Participant milestones

Measure	Rifaximin Participants will receive a 10-day course of Rifaximin 550mg PO BID. Rifaximin: 550mg pills	Placebo Participants will receive a 10-day course of placebo PO BID. Placebo: Placebo pill
Overall Study STARTED	19	19
Overall Study COMPLETED	17	14
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Rifaximin Participants will receive a 10-day course of Rifaximin 550mg PO BID. Rifaximin: 550mg pills	Placebo Participants will receive a 10-day course of placebo PO BID. Placebo: Placebo pill
Overall Study Acute illness, unrelated to study drug	2	3
Overall Study Protocol Violation	0	2

Baseline Characteristics

Rifaximin Therapy in Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Rifaximin n=17 Participants Participants will receive a 10-day course of Rifaximin. Rifaximin: 550mg PO BID	Placebo n=14 Participants Participants will receive a 10-day course of placebo. Placebo: Placebo PO BID	Total n=31 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 13 • n=5 Participants	65 years STANDARD_DEVIATION 9 • n=7 Participants	64 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body mass index	31 kg/m^2 STANDARD_DEVIATION 8 • n=5 Participants	35 kg/m^2 STANDARD_DEVIATION 9 • n=7 Participants	33 kg/m^2 STANDARD_DEVIATION 8 • n=5 Participants
Diagnosis of diabetes	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Chronic kidney disease etiology Diabetes	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Chronic kidney disease etiology Glomerulonephritis	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Chronic kidney disease etiology Hypertension	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Chronic kidney disease etiology Polycystic kidney disease	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Chronic kidney disease etiology Other/unknown	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Estimated glomerular filtration rate	27.9 ml/min/1.73m^2 STANDARD_DEVIATION 10.6 • n=5 Participants	34.4 ml/min/1.73m^2 STANDARD_DEVIATION 14.2 • n=7 Participants	30.8 ml/min/1.73m^2 STANDARD_DEVIATION 12.6 • n=5 Participants
Serum Trimethylamine N-oxide	18.8 uM STANDARD_DEVIATION 18.7 • n=5 Participants	15.6 uM STANDARD_DEVIATION 11.6 • n=7 Participants	17.3 uM STANDARD_DEVIATION 15.7 • n=5 Participants
Serum P-cresol sulfate	18.5 ug/ml STANDARD_DEVIATION 10.0 • n=5 Participants	14.4 ug/ml STANDARD_DEVIATION 4.7 • n=7 Participants	16.7 ug/ml STANDARD_DEVIATION 8.2 • n=5 Participants
Serum indoxyl sulfate	3.7 ug/ml STANDARD_DEVIATION 2.0 • n=5 Participants	2.3 ug/ml STANDARD_DEVIATION 0.8 • n=7 Participants	3.1 ug/ml STANDARD_DEVIATION 1.8 • n=5 Participants
Serum kynurenic acid	28.1 ng/ml STANDARD_DEVIATION 21.3 • n=5 Participants	19.6 ng/ml STANDARD_DEVIATION 19.0 • n=7 Participants	24.3 ng/ml STANDARD_DEVIATION 16.8 • n=5 Participants
Serum deoxycholic acid	372.2 ng/ml STANDARD_DEVIATION 268.3 • n=5 Participants	609.8 ng/ml STANDARD_DEVIATION 384.7 • n=7 Participants	479.5 ng/ml STANDARD_DEVIATION 342.0 • n=5 Participants
Serum C-reactive protein	8.5 ug/ml STANDARD_DEVIATION 22.1 • n=5 Participants	8.2 ug/ml STANDARD_DEVIATION 11.6 • n=7 Participants	8.4 ug/ml STANDARD_DEVIATION 17.9 • n=5 Participants
Serum Interleukin-6	2.1 pg/ml STANDARD_DEVIATION 1.6 • n=5 Participants	3.3 pg/ml STANDARD_DEVIATION 2.6 • n=7 Participants	2.7 pg/ml STANDARD_DEVIATION 2.2 • n=5 Participants
Severity of Proteinuria None	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Severity of Proteinuria Mild	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Severity of Proteinuria Moderate	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to Day 11

Outcome measures

Measure	Rifaximin n=17 Participants Participants will receive a 10-day course of Rifaximin. Rifaximin: 550mg pills	Placebo n=14 Participants Participants will receive a 10-day course of placebo. Placebo: Placebo pill
Change in Serum Trimethylamine N-oxide (TMAO)	-3.9 uM Standard Deviation 15.4	0.5 uM Standard Deviation 9.5

SECONDARY outcome

Timeframe: Change from baseline to Day 11

Outcome measures

Measure	Rifaximin n=17 Participants Participants will receive a 10-day course of Rifaximin. Rifaximin: 550mg pills	Placebo n=14 Participants Participants will receive a 10-day course of placebo. Placebo: Placebo pill
C-reactive Protein	6.0 ug/ml Standard Deviation 19.7	-2.6 ug/ml Standard Deviation 5.8

SECONDARY outcome

Timeframe: Change from baseline to day 11

post- minus pre-treatment values

Outcome measures

Measure	Rifaximin n=17 Participants Participants will receive a 10-day course of Rifaximin. Rifaximin: 550mg pills	Placebo n=14 Participants Participants will receive a 10-day course of placebo. Placebo: Placebo pill
Change in Serum Interleukin-6 (IL-6)	0.3 pg/ml Standard Deviation 1.1	0.8 pg/ml Standard Deviation 2.1

Adverse Events

Rifaximin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rifaximin n=17 participants at risk Participants will receive a 10-day course of Rifaximin 550mg PO BID. Rifaximin: 550mg pills	Placebo n=14 participants at risk Participants will receive a 10-day course of placebo PO BID. Placebo: Placebo pill
Gastrointestinal disorders Cramping/diarrhea	0.00% 0/17 • 11 days	14.3% 2/14 • Number of events 2 • 11 days
Gastrointestinal disorders bleeding	5.9% 1/17 • Number of events 1 • 11 days	0.00% 0/14 • 11 days

Additional Information

Dr. Jason Stubbs

University of Kansas Medical Center

Phone: 9135886074

Email: jstubbs@kumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place