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

Primary Purpose

End Stage Renal Disease

Status

Withdrawn

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Rifaximin

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Kansas Medical Center
Westwood Dialysis Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rifaximin

Arm Description

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

Outcomes

Primary Outcome Measures

Change in serum TMAO levels

Secondary Outcome Measures

Change in serum TMAO levels

Change in fecal bacterial species

Change in fecal bacterial colony numbers

Change in fecal bacterial species

Change in fecal bacterial colony numbers

Full Information

NCT ID

NCT02738905

First Posted

April 5, 2016

Last Updated

February 26, 2019

Sponsor

Jason Stubbs, MD

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT02738905

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Withdrawn

Why Stopped

insufficient support

Study Start Date

January 2016 (undefined)

Primary Completion Date

February 26, 2019 (Actual)

Study Completion Date

February 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jason Stubbs, MD

Collaborators

American Heart Association

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rifaximin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rifaximin

Other Intervention Name(s)

XIFAXAN

Intervention Description

One 550 mg tablet taken orally two times a day.

Primary Outcome Measure Information:

Title

Change in serum TMAO levels

Time Frame

Change from Baseline to Day 7

Secondary Outcome Measure Information:

Title

Change in serum TMAO levels

Time Frame

Change from Baseline to Day 21

Title

Change in fecal bacterial species

Time Frame

Change from Baseline to Day 7

Title

Change in fecal bacterial colony numbers

Time Frame

Change from Baseline to Day 7

Title

Change in fecal bacterial species

Time Frame

Change from Baseline to Day 21

Title

Change in fecal bacterial colony numbers

Time Frame

Change from Baseline to Day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason Stubbs, MD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Westwood Dialysis Center

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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