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NCT02342639 Clinical Trial

Rifaximin Therapy in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:
Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02342639
Other study ID # STUDY00001638
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2015
Est. completion date March 1, 2019

Study information
Verified date October 2021
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date March 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Rifaximin
550mg pills
• Placebo
Placebo pill

Locations
Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)
Lead Sponsor Collaborator
Jason Stubbs, MD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Serum Trimethylamine N-oxide (TMAO) Change from baseline to Day 11
Secondary C-reactive Protein Change from baseline to Day 11
Secondary Change in Serum Interleukin-6 (IL-6) post- minus pre-treatment values Change from baseline to day 11
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