Rifaximin Therapy in Chronic Kidney Disease

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Rifaximin; Drug: Placebo

• Registration Number: NCT02342639
• Lead Sponsor: Jason Stubbs, MD

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 available

Study Timeline

• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-21
• Study Start: 2015-06
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Results First Submitted: 2021-09-15
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-08
• Last Update Submitted: 2021-10-08
• Results First Posted: 2021-11-05
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rifaximin	Rifaximin	Participants will receive a 10-day course of Rifaximin.
Placebo	Placebo	Participants will receive a 10-day course of placebo.

Primary Outcome Measures

Name	Time	Method
Change in Serum Trimethylamine N-oxide (TMAO)	Change from baseline to Day 11

Secondary Outcome Measures

Name	Time	Method
C-reactive Protein	Change from baseline to Day 11
Change in Serum Interleukin-6 (IL-6)	Change from baseline to day 11	post- minus pre-treatment values

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States