Rifaximin Therapy in Chronic Kidney Disease

Jason Stubbs, MD

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: Placebo; Drug: Rifaximin

Study type: Interventional

Funder types: Other

Identifiers

NCT02342639

STUDY00001638

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

Rifaximin

Experimental group

Description:

Participants will receive a 10-day course of Rifaximin.

Treatment:

Drug: Rifaximin

Placebo

Placebo Comparator group

Description:

Participants will receive a 10-day course of placebo.

Treatment:

Drug: Placebo