End Stage Renal DiseaseEarly Phase 1NCT02738905
Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease
A Early Phase 1 study testing Rifaximin in people with End Stage Renal Disease, run by Jason Stubbs, MD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Rifaximin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to 26 Feb 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of end-stage renal disease
- Receiving chronic intermittent hemodialysis
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
Westwood Dialysis Center
Westwood, Kansas, 66205
About this study
The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide (TMAO) levels in patients with end-stage renal disease.
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- Rifaximin
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called XIFAXAN
One 550 mg tablet taken orally two times a day.
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Experimental | Participants will receive study drug for a period of 7 days. Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum TMAO levels
Measured: Change from Baseline to Day 7
Secondary outcomes (5)
Change in serum TMAO levels
Measured: Change from Baseline to Day 21
Change in fecal bacterial species
Measured: Change from Baseline to Day 7
Change in fecal bacterial colony numbers
Measured: Change from Baseline to Day 7
Change in fecal bacterial species
Measured: Change from Baseline to Day 21
Change in fecal bacterial colony numbers
Measured: Change from Baseline to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startJan 2016
- Primary completion26 Feb 2019
- Study completion26 Feb 2019
Why it stopped: insufficient support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Stubbs, MD
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor-investigator, Jason Stubbs, MD, University of Kansas Medical Center
- Investigators
- Jason Stubbs, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738905
- Sponsor's protocol ID
- STUDY00004204
- Status last verified
- Feb 2019
- First submitted
- 5 Apr 2016
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT02738905
- Acronym / sponsor ID
- STUDY00004204
- Conditions
- End Stage Renal Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: insufficient support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jason Stubbs, MDUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jan 2016
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Experimental | Drug: RifaximinParticipants will receive study drug for a period of 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of end-stage renal disease
- Receiving chronic intermittent hemodialysis
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifaximinAlso: XIFAXANOne 550 mg tablet taken orally two times a day. | Drug | Rifaximin |
Primary outcome
Change in serum TMAO levels
Time frame: Change from Baseline to Day 7
5 secondary outcomes
Change in serum TMAO levels
Time frame: Change from Baseline to Day 21
Change in fecal bacterial species
Time frame: Change from Baseline to Day 7
Change in fecal bacterial colony numbers
Time frame: Change from Baseline to Day 7
Change in fecal bacterial species
Time frame: Change from Baseline to Day 21
Change in fecal bacterial colony numbers
Time frame: Change from Baseline to Day 21
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Stubbs, MD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rifaximin in people with End Stage Renal Disease, run by Jason Stubbs, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum TMAO levels (time frame: Change from Baseline to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.