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Role of Prohepcidin in Uremic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01735773
First Posted: November 28, 2012
Last Update Posted: November 28, 2012
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.
Information provided by (Responsible Party):
Haseki Training and Research Hospital
  Purpose
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.

Condition
Inflammation Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Relationship of Prohepcidin Levels With Anemia and Inflammatory Markers in Non-diabetic Uremic Patients: A Controlled Study

Further study details as provided by Haseki Training and Research Hospital:

Primary Outcome Measures:
  • prohepcidin level [ Time Frame: Six months ]
    Prohepcidin levels will be compared with other inflammatory markers.


Secondary Outcome Measures:
  • Anemia and inflammatory markers [ Time Frame: Six months ]
    Correlations of prohepcidin levels with anemia and inflamatory markers


Enrollment: 25
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 volunteers

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
  Contacts and Locations
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): NCT01735773


Locations
Turkey
Haseki Training and Research Hospital
Istanbul, Turkey, 34390
Sponsors and Collaborators
Haseki Training and Research Hospital
  More Information

Responsible Party: Haseki Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01735773     History of Changes
Other Study ID Numbers: HEPCIDIN-HASEKI
First Submitted: November 26, 2012
First Posted: November 28, 2012
Last Update Posted: November 28, 2012
Last Verified: November 2012

Keywords provided by Haseki Training and Research Hospital:
hemodialysis
inflammation
iron
peritoneal dialysis
prohepcidin
uremia

Additional relevant MeSH terms:
Inflammation
Kidney Diseases
Renal Insufficiency, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Hepcidins
Anti-Infective Agents