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

NCT02738905 | Withdrawn Early Phase 1

• 1 other identifier: STUDY00004204
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Change in serum TMAO levels

  Change from Baseline to Day 7

Secondary Outcomes (5)

• Change in serum TMAO levels

  Change from Baseline to Day 21

• Change in fecal bacterial species

  Change from Baseline to Day 7

• Change in fecal bacterial colony numbers

  Change from Baseline to Day 7

• Change in fecal bacterial species

  Change from Baseline to Day 21

• Change in fecal bacterial colony numbers

  Change from Baseline to Day 21

Study Arms (1)

Rifaximin

EXPERIMENTAL

Participants will receive study drug for a period of 7 days.

Drug: Rifaximin

Interventions

Rifaximin DRUG

One 550 mg tablet taken orally two times a day.

Also known as: XIFAXAN

Rifaximin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of end-stage renal disease
• Receiving chronic intermittent hemodialysis

You may not qualify if:

• 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

Sponsors & Collaborators

• Jason Stubbs, MD: lead
• American Heart Association: collaborator

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Westwood Dialysis Center

Westwood, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Jason Stubbs, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 14, 2016
• Study Start: January 1, 2016
• Primary Completion: February 26, 2019
• Study Completion: February 26, 2019
• Last Updated: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)