Clinical Trials Logo
  1. Home
  2. Chronic Kidney Disease
  3. NCT02342639
  4. Details
NCT02342639 Clinical Trial

Rifaximin Therapy in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:
Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02342639
Other study ID # STUDY00001638
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2015
Est. completion date March 1, 2019

Study information
Verified date October 2021
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date March 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rifaximin
550mg pills
• Placebo
Placebo pill

Locations
Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)
Lead Sponsor Collaborator
Jason Stubbs, MD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Serum Trimethylamine N-oxide (TMAO) Change from baseline to Day 11
Secondary C-reactive Protein Change from baseline to Day 11
Secondary Change in Serum Interleukin-6 (IL-6) post- minus pre-treatment values Change from baseline to day 11
See also
  Status Clinical Trial Phase
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed NCT05318014 - Low-protein Formula Supplements in Chronic Kidney Disease N/A
Active, not recruiting NCT06071065 - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients N/A
Completed NCT02878317 - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting NCT06039254 - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function Phase 1
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT02756520 - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Completed NCT02836574 - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease Phase 2
Withdrawn NCT02885545 - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial Phase 4
Completed NCT02896309 - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity N/A
Completed NCT02875886 - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease Phase 4
Active, not recruiting NCT02483039 - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization N/A
Terminated NCT02543177 - Optimised Procedure in Patients With NSTEMI and CKD N/A
Completed NCT02369549 - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease Phase 3
Completed NCT02992548 - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease Phase 4
Recruiting NCT02205944 - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes N/A
Active, not recruiting NCT02231138 - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease Phase 4