End Stage Renal DiseasePhase 2NCT03452189
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
A Phase 2 study testing Vancomycin in people with End Stage Renal Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine if multiple doses of vancomycin over the course of 3 months will perturb the intestinal flora (microbiome) and result in reduced serum concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 18 Aug 2018
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable chronic kidney disease on hemodialysis with a fistula or an AV graft.
Who cannot join
- Antibiotics received within the last 3 months;
- recent diarrhea
- known allergy to vancomycin
- history of C. difficile infection
- elevation of white blood cell count or fever within one week of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The purpose of this study is to determine if multiple doses of vancomycin over the course of 3 months will perturb the intestinal flora (microbiome) and result in reduced serum concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the study will permit investigators to assess the variability of serum uremic retention solute concentrations with and without antibiotic over a three-month period.
- Conditions
- End Stage Renal Disease
- Being tested
- Vancomycin, Placebo
- 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.
VancomycinDrug
Also called vancomycin hydrochloride capsules
Oral vancomycin 250mg capsules
PlaceboOther
Placebo Pills distributed by Research Pharmacy labeled "placebo."
| Study group | Role | What they receive |
|---|---|---|
| 250mg of oral vancomycin First | Active comparator | After 3 months, initial experimental group will be switched to placebo for 3 months. Receives: Drug: Vancomycin; Other: Placebo |
| Placebo First | Placebo comparator | After three months, the control group will be crossed over to weekly oral vancomycin (250mg) Receives: Drug: Vancomycin; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Concentration Measure of Indoxyl Sulphate (IS)
Plasma concentrations of IS were measured by HPLC (high pressure liquid chromatography).
Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported
Measured: 4 weeks
Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS)
Plasma concentrations of P-Cresyl Sulphate (PCS) were measured by HPLC (high pressure liquid chromatography)
Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start27 Nov 2017
- Primary completion18 Aug 2018
- Study completion18 Aug 2018
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.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized double-blinded placebo-controlled crossover study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerome Lowenstein, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452189
- Sponsor's protocol ID
- 17-00963
- Status last verified
- Mar 2021
- First submitted
- 23 Jan 2018
- Last updated
- 26 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
- ClinicalTrials.gov ID
- NCT03452189
- Acronym / sponsor ID
- 17-00963
- Conditions
- End Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 18 Aug 2018 (actual)
- Study completion
- 18 Aug 2018 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Posted 26 Mar 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 multiple doses of vancomycin over the course of 3 months will perturb the intestinal flora (microbiome) and result in reduced serum concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the study will permit investigators to assess the variability of serum uremic retention solute concentrations with and without antibiotic over a three-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- randomized double-blinded placebo-controlled crossover study
| Arm | Type | Receives |
|---|---|---|
| 250mg of oral vancomycin First | Active comparator | Drug: Vancomycin, Other: PlaceboAfter 3 months, initial experimental group will be switched to placebo for 3 months. |
| Placebo First | Placebo comparator | Drug: Vancomycin, Other: PlaceboAfter three months, the control group will be crossed over to weekly oral vancomycin (250mg) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with stable chronic kidney disease on hemodialysis with a fistula or an AV graft.
Key exclusion criteria (5 listed)
- Antibiotics received within the last 3 months;
- recent diarrhea
- known allergy to vancomycin
- history of C. difficile infection
- elevation of white blood cell count or fever within one week of enrollment.
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 |
|---|---|---|
| VancomycinAlso: vancomycin hydrochloride capsulesOral vancomycin 250mg capsules | Drug | 250mg of oral vancomycin First, Placebo First |
| PlaceboPlacebo Pills distributed by Research Pharmacy labeled "placebo." | Other | 250mg of oral vancomycin First, Placebo First |
Primary outcome
Change in Plasma Concentration Measure of Indoxyl Sulphate (IS)
Time frame: 4 weeks
Plasma concentrations of IS were measured by HPLC (high pressure liquid chromatography). Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported
Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS)
Time frame: 4 weeks
Plasma concentrations of P-Cresyl Sulphate (PCS) were measured by HPLC (high pressure liquid chromatography) Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Jerome Lowenstein, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vancomycin in people with End Stage Renal Disease, run by NYU Langone Health 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 5 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 26 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Mar 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 Plasma Concentration Measure of Indoxyl Sulphate (IS) (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 26 Mar 2021.