NCT02342639

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 5, 2021

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

3.8 years

First QC Date

January 15, 2015

Results QC Date

September 15, 2021

Last Update Submit

October 8, 2021

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Change in Serum Trimethylamine N-oxide (TMAO)

    Change from baseline to Day 11

Secondary Outcomes (2)

  • C-reactive Protein

    Change from baseline to Day 11

  • Change in Serum Interleukin-6 (IL-6)

    Change from baseline to day 11

Study Arms (2)

Rifaximin

EXPERIMENTAL

Participants will receive a 10-day course of Rifaximin.

Drug: Rifaximin

Placebo

PLACEBO COMPARATOR

Participants will receive a 10-day course of placebo.

Drug: Placebo

Interventions

RifaximinDRUG

550mg pills

Also known as: XIFAXAN®
Rifaximin
PlaceboDRUG

Placebo pill

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Kimber C, Zhang S, Johnson C, West RE 3rd, Prokopienko AJ, Mahnken JD, Yu AS, Hoofnagle AN, Ir D, Robertson CE, Miyazaki M, Chonchol M, Jovanovich A, Kestenbaum B, Frank DN, Nolin TD, Stubbs JR. Randomized, Placebo-Controlled Trial of Rifaximin Therapy for Lowering Gut-Derived Cardiovascular Toxins and Inflammation in CKD. Kidney360. 2020 Nov;1(11):1206-1216. doi: 10.34067/kid.0003942020. Epub 2020 Nov 25.

    PMID: 34322673DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Jason Stubbs
Organization
University of Kansas Medical Center
jstubbs@kumc.edu
9135886074

Study Officials

  • Jason Stubbs, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 21, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

November 5, 2021

Results First Posted

November 5, 2021

Record last verified: 2021-10

Locations

US(1)