The Role of P-cresol and Related Protein Fermentation Metabolites in Chronic Kidney Disease Patients
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|ClinicalTrials.gov Identifier: NCT00441623|
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment|
|Chronic Kidney Disease||Behavioral: observational|
Protein-bound uremic retention solutes are increasingly recognized to play a role in the pathophysiology of the uremic syndrome. Numerous in vitro findings are indicative for their implication in the biochemical and physiological changes of uremia. Several of these protein-bound retention solutes originate from bacterial protein fermentation in the colon. p-cresyl sulfate, a fermentation metabolite of the amino acid tyrosine, is considered a prototype of this group of uremic solutes. The protein binding of this molecule was shown to be about 90% in end-stage renal disease patients. Several data have suggested that p-cresol plays a role in the immunodeficiency of uremia. Recently, a link between the molecule and endothelial dysfunction has been demonstrated. Also other members of the class of protein-bound solutes have been found to be associated with immune dysfunction, endothelial cell dysfunction and, closely related to the latter, oxidative stress.
Free serum levels of p-cresol were shown to be greater in stage 5 chronic kidney disease (CKD) patients treated with hemodialysis (HD) hospitalized for infectious disease. Furthermore, a positive relationship was found between serum total p-cresol level and a uremic symptom score in patients treated with peritoneal dialysis (PD), whereas a correlation with small water-soluble solutes and the middle molecule β2-microglobulin was absent. A recent prospective observational study in stage 5 CKD patients treated with conventional HD (3 x 4 hours per week) indicated that the accumulation of p-cresol is a risk factor for overall mortality.
Data on the serum concentrations of p-cresol in chronic kidney disease patients are lacking. The investigators hypothesise that the serum concentration of p-cresol is an independent predictor of progression to end stage renal disease and is an independent predictor for cardiovascular disease.
|Study Type :||Observational|
|Actual Enrollment :||499 participants|
|Official Title:||A Single Centre Observational Cohort Study on the Prognostic Relevance of P-cresol and Related Uremic Retention Solutes in the Development and/or Progression of Renal Failure and Cardiovascular Disease in Chronic Kidney Disease Patients|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
- Behavioral: observational
effect of protein-bound uremic retention solutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441623
|Universitaire Ziekenhuizen Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Björn KI Meijers, MD||Universitaire Ziekenhuizen Leuven|
|Study Director:||Pieter Evenepoel, MD, PhD||Universitaire Ziekenhuizen Leuven|