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

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ClinicalTrials.gov Identifier: NCT02738905
Recruitment Status : Active, not recruiting
First Posted : April 14, 2016
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Jason Stubbs, MD, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: Rifaximin Early Phase 1

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease
Study Start Date : July 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Rifaximin
Participants will receive study drug for a period of 7 days.
Drug: Rifaximin
One 550 mg tablet taken orally two times a day.
Other Name: XIFAXAN




Primary Outcome Measures :
  1. Change in serum TMAO levels [ Time Frame: Change from Baseline to Day 7 ]

Secondary Outcome Measures :
  1. Change in serum TMAO levels [ Time Frame: Change from Baseline to Day 21 ]
  2. Change in fecal bacterial species [ Time Frame: Change from Baseline to Day 7 ]
  3. Change in fecal bacterial colony numbers [ Time Frame: Change from Baseline to Day 7 ]
  4. Change in fecal bacterial species [ Time Frame: Change from Baseline to Day 21 ]
  5. Change in fecal bacterial colony numbers [ Time Frame: Change from Baseline to Day 21 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738905


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Westwood Dialysis Center
Westwood, Kansas, United States, 66205
Sponsors and Collaborators
Jason Stubbs, MD
American Heart Association
Investigators
Principal Investigator: Jason Stubbs, MD University of Kansas Medical Center

Responsible Party: Jason Stubbs, MD, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02738905     History of Changes
Other Study ID Numbers: STUDY00004204
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Rifaximin
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents