P-cresol: Correlation With Glomerular Filtration Rate and Outcome in Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
iwenwu, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00888030
First received: April 22, 2009
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

End-stage renal disease is a global epidemia with an estimated incidence of 7% per year and high morbidity-mortality rate. Early detection of chronic kidney disease (CKD) and intervention for CKD complication is important to retard renal progression. However, "traditional uremic toxin" or "small water-soluble molecules" are poorly correlated with the renal function, uremic symptoms and outcomes of CKD patients.

Putative protein-bound solute, p-cresol, is accumulated in ESRD patients receiving dialysis therapy. This uremic solute was associated with endothelial dysfunction, immune dysregulation and can predict outcome in hemodialysis patient. P-cresol inhibits endothelial cell proliferation and endothelial response to inflammatory cytokines. In vitro, p-cresol decreases leukocyte transendotherliar migratory function and inhibit production of phagocyte reactive species. Clinically, p-cresol plays a pathophysiological role in the uremic toxicity. High free serum level of p-cresol is associated with mortality in hemodialysis patients.

Information of p-cresol in CKD patients is not available. The investigators hypothesized p-cresol can be accumulated in early CKD and have a positive correlation with the morbidity- mortality of CKD patients.

Value of p-cresol in different stages of CRF is still unknown. Information of p-cresol in CKD patients is not available. The investigators hypothesized p-cresol can be accumulated in early CKD and have a positive correlation with the morbidity- mortality of CKD patients.

The principal aim of this prospective cohort study is to investigate the association between total serum levels of p-cresol and the glomerular filtration rate. The correlation of level of p-cresol and morbidity-mortality in CKD patients will be also evaluated.

To determine the relationship, patients of nephrology clinic with a diagnosis of CKD were enrolled in this prospective study and follow-up for 1-year period. The association between total and free serum levels of p-cresol and the glomerular filtration rate were evaluated in CKD patients. The p-cresol level was correlated with other many inflammatory markers (white blood cell counts, ferritin, hs-crp, leptin) and also with the hospitalization rate secondary to cardiovascular and infectious event. The renal outcome and all-cause mortality was assessed. Determination of this relationship can help to establish an accurate marker for early detection of CKD and also its prognostic role in CKD patients.


Condition Intervention
Risk Factors
Renal Progression
Death
Other: there are no interventions currently listed for this study

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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • end stage renal disease, reduction of eGFR by 50% and death [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum level of p-cresol and indoxyl sulfate


Enrollment: 300
Study Start Date: May 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
2
CKD patients with normal p-cresol
Other: there are no interventions currently listed for this study
3
CKD patient with normal indoxyl sulfate
Other: there are no interventions currently listed for this study
4
CKD patients with high indoxyl sulfate
Other: there are no interventions currently listed for this study
1
CKD patients with high p cresol
Other: there are no interventions currently listed for this study

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All CKD patients attended at out-patient department of nephrology were included for analysis. The inclusion criteria were adults aged > 18 y/o or < 80 y/o; estimated GFR or CCR < 60 ml/min; no spontaneous renal improvement or progression in past 3 months.

Criteria

Inclusion Criteria:

  • All CKD patients attended at out-patient department of nephrology were included for analysis.
  • The inclusion criteria were adults aged > 18 y/o or < 80 y/o
  • Estimated GFR or CCR < 60 ml/min
  • No spontaneous renal improvement or progression in past 3 months.

Exclusion Criteria:

  • Recent cardiovascular disease (Coronary artery disease, myocardial ischemia, cerebrovascular disease or peripheral artery disease) in past 3 months
  • Recent infections requiring admission in past 3 months
  • Uncontrolled hypertension
  • Serum albumin level < 2.5mg/dL
  • Unwilling to participate in the trial.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00888030

Locations
Taiwan
Department of Nephrology,Chang Gung Memorial Hospital
Keelung, Taiwan, 204
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Iwen Wu, MD Chang Gung Memorial Hospital
  More Information

Publications:
Responsible Party: iwenwu, Attending physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00888030     History of Changes
Other Study ID Numbers: IWW-0003
Study First Received: April 22, 2009
Last Updated: September 5, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
p-cresol
indoxyl sulfate
chronic kidney disease
outcome

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

ClinicalTrials.gov processed this record on July 24, 2014