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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02738905
• Other study ID #: STUDY00004204
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: January 2016
• Est. completion date: February 26, 2019

Study information

• Verified date: February 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study participants will undergo 3 study visits: baseline, day 7 (immediately post-therapy), day 21 (2 weeks post-therapy). All participants will provide blood and stool samples at each visit.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 26, 2019
• Est. primary completion date: February 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Rifaximin
One 550 mg tablet taken orally two times a day.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Westwood Dialysis Center	Westwood	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Jason Stubbs, MD	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum TMAO levels		Change from Baseline to Day 7
Secondary	Change in serum TMAO levels		Change from Baseline to Day 21
Secondary	Change in fecal bacterial species		Change from Baseline to Day 7
Secondary	Change in fecal bacterial colony numbers		Change from Baseline to Day 7
Secondary	Change in fecal bacterial species		Change from Baseline to Day 21
Secondary	Change in fecal bacterial colony numbers		Change from Baseline to Day 21