Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease

• Status: Withdrawn
• Trial end date: 2019-02-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide (TMAO) levels in patients with end-stage renal disease.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jason Stubbs, MD
• Collaborator: American Heart Association
• Treatments: Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• Diagnosis of end-stage renal disease

• Receiving chronic intermittent hemodialysis

Exclusion Criteria:

• Patients with less advanced kidney disease

• Inability or unwillingness to provide informed consent

• 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, or recent (within the last 2 months) use of antibiotics