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Role of Prohepcidin in Uremic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haseki Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01735773
First received: November 26, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • prohepcidin level [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Prohepcidin levels will be compared with other inflammatory markers.


Secondary Outcome Measures:
  • Anemia and inflammatory markers [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735773

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

No publications provided

Responsible Party: Haseki Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01735773     History of Changes
Other Study ID Numbers: HEPCIDIN-HASEKI
Study First Received: November 26, 2012
Last Updated: November 27, 2012
Health Authority: Turkey: Ministry of Health

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
Kidney Failure, Chronic
 Pathologic Processes
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 22, 2013