Role of Prohepcidin in Uremic Patients

November 27, 2012 updated by: Haseki Training and Research Hospital

The Relationship of Prohepcidin Levels With Anemia and Inflammatory Markers in Non-diabetic Uremic Patients: A Controlled Study

The investigators aimed to study the effect of prohepcidin levels on hematologic parameters and inflammatory markers in non-diabetic uremic patients. The investigators selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also. Each group has been planned to be formed of about 25 patients. Diabetic patients were excluded. Prohepcidin, hsCRP, IL-6, fibrinogen have been planned to be studied besides other routine biochemical analysis including hematological ones.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34390
        • Haseki Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also.

Description

Inclusion Criteria:

  • hemodialysis and peritoneal dialysis patients who had been on dialysis therapy for more than 3 months,
  • age between 18-80 years,
  • patients with creatinine clearance between 15-30 ml/min.

Exclusion Criteria:

  • age less than 18 or more than 80,
  • diabetic patients,
  • current active infectious or inflammatory disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
Healthy volunteers
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prohepcidin level
Time Frame: Six months
Prohepcidin levels will be compared with other inflammatory markers.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anemia and inflammatory markers
Time Frame: Six months
Correlations of prohepcidin levels with anemia and inflamatory markers
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haseki Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (ESTIMATE)

November 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPCIDIN-HASEKI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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