The Role of P-cresol and Related Protein Fermentation Metabolites in Chronic Kidney Disease Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00441623
First received: February 28, 2007
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Behavioral: observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Biospecimen Retention:   Samples Without DNA

Serum, plasma Urine (if provided by patient)


Estimated Enrollment: 500
Study Start Date: October 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: observational
    effect of protein-bound uremic retention solutes
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

chronic kidney disease patients KDOQI stage 1-5 not yet on dialysis

Criteria

Inclusion Criteria:

  • Informed consent
  • Chronic kidney disease, stage 1-4 kDOQI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441623

Locations
Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Björn KI Meijers, MD Universitaire Ziekenhuizen Leuven
Study Director: Pieter Evenepoel, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided by Universitaire Ziekenhuizen Leuven

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Björn Meijers, Prof, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT00441623     History of Changes
Other Study ID Numbers: PCS001
Study First Received: February 28, 2007
Last Updated: December 16, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
chronic kidney disease
cardiovascular disease
risk stratification

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 15, 2014