NCT01874210|Completed
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Sponsor study identifier
observational
65
1 country
1
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2016
Actual (reported)Study Completion
May 2016
Actual (reported)Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. Indirect findings suggest that chronic kidney disease influences the colonic microbial metabolism with higher p-cresyl sulfate urinary excretion rates at more advanced renal disease. Therefore, this study aims to elucidate the influence of renal dysfunction on microbial metabolism and to test the hypothesis that chronic kidney disease patients carry a different fecal metabolite profile.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
June 6, 2013
Actual (reported)June 10, 2013
Actual (reported)May 2016
Actual (reported)May 2016
Actual (reported)difference in fecal metabolite profile (Chronic kidney disease vs. control)
difference in fecal metabolite profile between chronic kidney disease patients and control group
baseline
difference in fecal metabolite profile depending on dialysis modality
baseline
Hemodialysis patients
1. Household contacts on the same diet 2. Healthy unrelated controls
Patients treated with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Fecal sample, serum
Ruben Poesen, MD
Universitaire Ziekenhuizen KU Leuven
Björn Meijers, MD, PhD
Universitaire Ziekenhuizen KU Leuven
Kristin Verbeke, Pharm PhD
Universitaire Ziekenhuizen KU Leuven
Pieter Evenepoel, MD, PhD
Universitaire Ziekenhuizen KU Leuven
65 participants (actual enrollment reported by the registry).
First Submitted
June 6, 2013
First Posted
June 10, 2013
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality
Contact the study team to confirm eligibility.
Primary Completion
May 2016
Actual (reported)Study Completion
May 2016
Actual (reported)Last Updated
May 18, 2016
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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