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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00441623
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven

Brief Summary:
Study on the natural history of uremic retention solutes in patients with mild-to-moderate chronic kidney disease

Condition or disease Intervention/treatment
Chronic Kidney Disease Behavioral: observational

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 499 participants
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
Study Start Date : October 2005
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Cresol

Intervention Details:
  • Behavioral: observational
    effect of protein-bound uremic retention solutes

Biospecimen Retention:   Samples Without DNA
Serum, plasma Urine (if provided by patient)

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
chronic kidney disease patients KDOQI stage 1-5 not yet on dialysis

Inclusion Criteria:

  • Informed consent
  • Chronic kidney disease, stage 1-4 kDOQI

Exclusion criteria

  • age below 18
  • Kidney transplant recipient

Information from the National Library of Medicine

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 identifier (NCT number): NCT00441623

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Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Björn KI Meijers, MD Universitaire Ziekenhuizen Leuven
Study Director: Pieter Evenepoel, MD, PhD Universitaire Ziekenhuizen Leuven
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Björn Meijers, Prof, Universitaire Ziekenhuizen Leuven Identifier: NCT00441623    
Other Study ID Numbers: PCS001
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Björn Meijers, Universitaire Ziekenhuizen Leuven:
chronic kidney disease
cardiovascular disease
risk stratification
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency