A Phase 2 interventional study of Vancomycin and Placebo in End Stage Renal Disease, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-26.
Sponsored by NYU Langone Health · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
After 3 months, initial experimental group will be switched to placebo for 3 months.
Drug: Vancomycin · Other: Placebo
After three months, the control group will be crossed over to weekly oral vancomycin (250mg)
Drug: Vancomycin · Other: Placebo
Oral vancomycin 250mg capsules
Also known as: vancomycin hydrochloride capsules
Placebo Pills distributed by Research Pharmacy labeled "placebo."
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
Time frame: 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
Time frame: 4 weeks
| Milestone | 250mg of Oral Vancomycin First, Then Placebo | Placebo First, Then 250mg of Oral Vancomycin |
|---|---|---|
| Started | 10 | 5 |
| Completed | 5 | 5 |
| Not completed | 5 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Insufficient samples of plasma and stool | 4 | 0 |
| Milestone | 250mg of Oral Vancomycin First, Then Placebo | Placebo First, Then 250mg of Oral Vancomycin |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
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
| µM/ml | 250mg of Oral Vancomycin First, Then Placebo | Placebo First, Then 250mg of Oral Vancomycin |
|---|---|---|
| Change in Plasma Concentration Measure of Indoxyl Sulphate (IS) | -25.31 ± 36.3 | 9.71 ± 49.80 |
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
| µM/ml | 250mg of Oral Vancomycin First, Then Placebo | Placebo First, Then 250mg of Oral Vancomycin |
|---|---|---|
| Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS) | -73.51 ± 127.00 | 0.64 ± 79.50 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 250mg of Oral Vancomycin First | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Placebo First | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Placebo First or 250mg of Oral Vancomycin First (Crossover After 3 Months) |
|---|---|
| Mean | 57.6 ± 9 |
| Sex: Female, Male(Participants) | Placebo First or 250mg of Oral Vancomycin First (Crossover After 3 Months) |
|---|---|
| Female | 4 |
| Male | 11 |
| Race/Ethnicity, Customized(Participants) | Placebo First or 250mg of Oral Vancomycin First (Crossover After 3 Months) |
|---|---|
| White | 2 |
| Black | 3 |
| Asian | 2 |
| Hispanic | 6 |
| Other or more than one | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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