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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 250mg of oral vancomycin First | Active Comparator | After 3 months, initial experimental group will be switched to placebo for 3 months. |
|
| Placebo First | Placebo Comparator | After three months, the control group will be crossed over to weekly oral vancomycin (250mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | Oral vancomycin 250mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome Lowenstein, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 250mg of Oral Vancomycin First, Then Placebo | 250mg of Oral Vancomycin given for 3 months then crossed over to placebo for additional 3 months (no washout period). |
| FG001 | Placebo First, Then 250mg of Oral Vancomycin | Placebo given for 3 months then crossed over to 250 mg of Oral Vancomycin for additional 3 months (no washout period). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Months) |
|
| |||||||||||||||||||||
| Intervention 2 (3 Months) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo First or 250mg of Oral Vancomycin First (Crossover After 3 Months) | Total cohort |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | As there was no "washout period" following vancomycin, for the analysis of vancomycin effect, investigators compared the changes in solute levels in all 10 subjects while receiving vancomycin to the changes seen in the 5 "Z" series subjects while receiving placebo as the initial treatment. | Posted | Mean | Standard Deviation | µM/ml | 4 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 250mg of Oral Vancomycin First | After 3 months, initial experimental group will be switched to placebo for 3 months. Vancomycin: Oral vancomycin 250mg capsules Placebo: Placebo Pills distributed by Research Pharmacy labeled "placebo." |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerome Lowenstein | NYU Langone Health | +1 212 263 5635 | Jerome.Lowenstein@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2017 | Oct 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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randomized double-blinded placebo-controlled crossover study
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| Placebo | Other | Placebo Pills distributed by Research Pharmacy labeled "placebo." |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Placebo First, Then 250mg of Oral Vancomycin |
Placebo given for 3 months then crossed over to 250 mg of Oral Vancomycin for additional 3 months (no washout period). |
|
|
| Primary | 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 | As there was no "washout period" following vancomycin, for the analysis of vancomycin effect, investigators compared the changes in solute levels in all 10 subjects while receiving vancomycin to the changes seen in the 5 "Z" series subjects while receiving placebo as the initial treatment. | Posted | Mean | Standard Deviation | µM/ml | 4 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Placebo First | After three months, the control group will be crossed over to weekly oral vancomycin (250mg) Vancomycin: Oral vancomycin 250mg capsules Placebo: Placebo Pills distributed by Research Pharmacy labeled "placebo." | 0 | 5 | 0 | 5 | 0 | 5 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |