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OpenTrials
Completed

NCT Number: NCT02342639

Rifaximin Therapy in Chronic Kidney Disease

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifaximin

Drug

550mg pills

Other names: XIFAXAN®

Placebo

Drug

Placebo pill

Primary outcomes

  1. Change in Serum Trimethylamine N-oxide (TMAO)

    Time frame: Change from baseline to Day 11

Secondary outcomes

  1. C-reactive Protein

    Time frame: Change from baseline to Day 11

  2. Change in Serum Interleukin-6 (IL-6)

    Time frame: Change from baseline to day 11

    post- minus pre-treatment values

Sponsors and collaborators

Lead sponsor

Jason Stubbs, MD

Other

Registry information

Official study title

Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 21, 2015
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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