Phase 4 N=38 Randomized Triple-blind Prevention

Rifaximin Therapy in Chronic Kidney Disease

Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT02342639 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcome: Primary: Change in Serum Trimethylamine N-oxide (TMAO) — -3.9; 0.5 uM

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Rifaximin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Jason Stubbs, MD
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Serum Trimethylamine N-oxide (TMAO)	-3.9; 0.5	—
SECONDARY C-reactive Protein	6.0; -2.6	—
SECONDARY Change in Serum Interleukin-6 (IL-6)	0.3; 0.8	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02342639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.