Chronic Kidney DiseasePhase 4NCT02342639
Rifaximin Therapy in Chronic Kidney Disease
A Phase 4 study testing Rifaximin in people with Chronic Kidney Disease, run by Jason Stubbs, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Rifaximin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 1 Mar 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Rifaximin, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called XIFAXAN®
550mg pills
PlaceboDrug
Placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Experimental | Participants will receive a 10-day course of Rifaximin. Receives: Drug: Rifaximin |
| Placebo | Placebo comparator | Participants will receive a 10-day course of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Trimethylamine N-oxide (TMAO)
Measured: Change from baseline to Day 11
Secondary outcomes (2)
C-reactive Protein
Measured: Change from baseline to Day 11
Change in Serum Interleukin-6 (IL-6)
post- minus pre-treatment values
Measured: Change from baseline to day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startJun 2015
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney 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
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Stubbs, MD
- Sponsor type
- University, hospital or other
- 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
- NCT02342639
- Sponsor's protocol ID
- STUDY00001638
- Status last verified
- Oct 2021
- First submitted
- 15 Jan 2015
- Last updated
- 5 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34322673
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02342639
- Acronym / sponsor ID
- STUDY00001638
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Jason Stubbs, MDUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Posted 5 Nov 2021
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Experimental | Drug: RifaximinParticipants will receive a 10-day course of Rifaximin. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a 10-day course of placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2
Key exclusion criteria (9 listed)
- 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
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: XIFAXAN®550mg pills | Drug | Rifaximin |
| PlaceboPlacebo pill | Drug | Placebo |
Primary outcome
Change in Serum Trimethylamine N-oxide (TMAO)
Time frame: Change from baseline to Day 11
2 secondary outcomes
C-reactive Protein
Time frame: Change from baseline to Day 11
Change in Serum Interleukin-6 (IL-6)
Time frame: Change from baseline to day 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34322673Kimber 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.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifaximin in people with Chronic Kidney Disease, run by Jason Stubbs, MD at 1 site 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Trimethylamine N-oxide (TMAO) (time frame: Change from baseline to Day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02342639, which also lists 1 linked publication.
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 5 Nov 2021.