Phase 4
Completed N=38
Rifaximin Therapy in Chronic Kidney Disease
Source: ClinicalTrials.gov NCT02342639 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Change in Serum Trimethylamine N-oxide (TMAO) — -3.9; 0.5 uM
◆ Published Evidence
Established
22citations · ~4 / year
Randomized, Placebo-Controlled Trial of Rifaximin Therapy for Lowering Gut-Derived Cardiovascular Toxins and Inflammation in CKD.
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.
Linked Publications
-
Randomized, Placebo-Controlled Trial of Rifaximin Therapy for Lowering Gut-Derived Cardiovascular Toxins and Inflammation in CKD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Trimethylamine N-oxide (TMAO) |
-3.9; 0.5 | — |
| SECONDARY C-reactive Protein |
6.0; -2.6 | — |
| SECONDARY Change in Serum Interleukin-6 (IL-6) |
0.3; 0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT02342639) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.