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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin | Experimental | Participants will receive a 10-day course of Rifaximin. |
|
| Placebo | Placebo Comparator | Participants will receive a 10-day course of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | 550mg pills |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Trimethylamine N-oxide (TMAO) | Change from baseline to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive Protein | Change from baseline to Day 11 | |
| Change in Serum Interleukin-6 (IL-6) | post- minus pre-treatment values | Change from baseline to day 11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Stubbs, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34322673 | Derived | 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. |
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Recruitment period: June 2015 - January 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | Rifaximin | Participants will receive a 10-day course of Rifaximin 550mg PO BID. Rifaximin: 550mg pills |
| FG001 | Placebo | Participants will receive a 10-day course of placebo PO BID. Placebo: Placebo pill |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rifaximin | Participants will receive a 10-day course of Rifaximin. Rifaximin: 550mg PO BID |
| BG001 | Placebo | Participants will receive a 10-day course of placebo. Placebo: Placebo PO BID |
| 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 Serum Trimethylamine N-oxide (TMAO) | Posted | Mean | Standard Deviation | uM | Change from baseline to Day 11 |
|
|
11 days
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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 | Rifaximin | Participants will receive a 10-day course of Rifaximin 550mg PO BID. Rifaximin: 550mg pills |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cramping/diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Stubbs | University of Kansas Medical Center | 9135886074 | jstubbs@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 11, 2015 | Sep 15, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
Placebo pill |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Diagnosis of diabetes | Patients with a known diagnosis of diabetes mellitus | Count of Participants | Participants |
|
| Chronic kidney disease etiology | Count of Participants | Participants |
|
| Estimated glomerular filtration rate | Mean | Standard Deviation | ml/min/1.73m^2 |
|
| Serum Trimethylamine N-oxide | Mean | Standard Deviation | uM |
|
| Serum P-cresol sulfate | Mean | Standard Deviation | ug/ml |
|
| Serum indoxyl sulfate | Mean | Standard Deviation | ug/ml |
|
| Serum kynurenic acid | Mean | Standard Deviation | ng/ml |
|
| Serum deoxycholic acid | Mean | Standard Deviation | ng/ml |
|
| Serum C-reactive protein | Mean | Standard Deviation | ug/ml |
|
| Serum Interleukin-6 | Mean | Standard Deviation | pg/ml |
|
| Severity of Proteinuria | Count of Participants | Participants |
|
|
| Secondary | C-reactive Protein | Posted | Mean | Standard Deviation | ug/ml | Change from baseline to Day 11 |
|
|
|
| Secondary | Change in Serum Interleukin-6 (IL-6) | post- minus pre-treatment values | Posted | Mean | Standard Deviation | pg/ml | Change from baseline to day 11 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Placebo | Participants will receive a 10-day course of placebo PO BID. Placebo: Placebo pill | 0 | 14 | 0 | 14 | 2 | 14 |
| bleeding | Gastrointestinal disorders | Systematic Assessment | GI bleeding - supra-therapeutic INR |
|
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| 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 |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |