Impact of Rifaximin Therapy on Intestinal Byproducts in E... | NCT02738905

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

NCT02738905

Sponsor

Jason Stubbs, MD

Status

Withdrawn

Last Update Posted

Feb 28, 2019Actual

Enrollment

0Actual

Phase

Early Phase 1

Conditions

End Stage Renal Disease

Interventions

Rifaximin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient support

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Feb 26, 2019Actual

Completion Date

Feb 26, 2019Actual

First Submitted Date

Apr 5, 2016

First Submission Date that Met QC Criteria

Apr 11, 2016

First Posted Date

Apr 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2019

Last Update Posted Date

Feb 28, 2019Actual

Name	Class
American Heart Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rifaximin	Experimental	Participants will receive study drug for a period of 7 days.	Drug: Rifaximin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rifaximin	Drug	One 550 mg tablet taken orally two times a day.	Rifaximin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in serum TMAO levels		Change from Baseline to Day 7

Secondary Outcomes

Measure	Description	Time Frame
Change in serum TMAO levels		Change from Baseline to Day 21
Change in fecal bacterial species		Change from Baseline to Day 7
Change in fecal bacterial colony numbers

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason Stubbs, MD	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States
Westwood Dialysis Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078262	Rifaximin

Ancestor Terms

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided