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Pentraxin-3 in Chronic Renal Failure

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ClinicalTrials.gov Identifier: NCT01397773
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : July 20, 2011
Information provided by:
Haseki Training and Research Hospital

Brief Summary:
The aim of the study is to measure Pentraxin-3 levels in patients on hemodialysis, peritoneal dialysis and those in the pre-dialysis period; and to compare these groups with the control group; so as to investigate the eligibility of it as a reliable marker of inflammation; relationship with other inflammatory markers and carotis intima media thickness.

Condition or disease
Inflammation Chronic Kidney Disease

Detailed Description:
The investigators planned to involve four group of patients: Hemodialysis, peritoneal dialysis, pre-dialysis and the control group; with about 25 patients planned to be involved in each group. The laboratory parameters to be measured are Pentraxin-3, C-reactive protein (CRP), high sensitive CRP, fibrinogen and interleukin-6. Concomitantly, carotis intima media thickness will be measured in the radiology clinic. Statistical analysis will be carried on by Statistical Package for Social Sciences (SPSS) for Windows 13.0. The variables acting on the inflammatory parameters and the correlation between them and carotis intima media thickness will be studied.

Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Role Pentraxin-3 in the Inflammatory Process in Chronic Renal Failure, and the Association With Other Inflammatory Parameters
Study Start Date : April 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Hemodialysis group
Patients on chronic hemodialysis program
Peritoneal dialysis group
Patients on chronic peritoneal dialysis program
Pre-dialysis group
Patients with chronic kidney disease stage-4
Control group
Healthy subjects

Primary Outcome Measures :
  1. Pentraxin-3 level [ Time Frame: Five months ]
    Pentraxin-3 level will be compared with other inflammatory markers.

Secondary Outcome Measures :
  1. Carotis intima media thickness [ Time Frame: Five months ]
    Correlation of Pentraxin-3 and carotis intima media thickness

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected among those who are followed up in our clinic.

Inclusion Criteria:

  • To give informed consent
  • Hemodialysis or peritoneal dialysis for more than 3 months
  • Creatinin clearance less than 30 ml/min for the pre-dialysis group

Exclusion Criteria:

  • Not to give informed concent
  • Active infection within the last 3 months
  • Known chronic inflammatory disease

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 ClinicalTrials.gov identifier (NCT number): NCT01397773

Haseki Training and Research Hospital
Istanbul, Turkey, 34390
Sponsors and Collaborators
Haseki Training and Research Hospital

Responsible Party: Meltem Gursu, Haseki Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01397773     History of Changes
Other Study ID Numbers: PTX-HASEKI
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Haseki Training and Research Hospital:
peritoneal dialysis
chronic kidney disease
carotis intima media thickness

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