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Prohepcidin, Inflammation and Iron Homeostasis in Hemodialysis Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272479
First Posted: January 7, 2011
Last Update Posted: January 7, 2011
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:
Istanbul University
  Purpose
The aim of this study is to address questions regarding the link among hepcidin, hematological iron markers, inflammation and hepatitis C in HD patients. In attempt to address this issue, we planned to measure serum levels of hepcidin prohormone (pro-hepcidin), inflammatory and iron parameters.

Condition
Renal Failure Chronic Requiring Hemodialysis Hepatitis C

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Comparison of Prohepcidin, Inflammation and Iron Homeostasis in Hemodialysis Patients With and Without Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Primary Outcome Measures:
  • Association of prohepcidin and inflammation [ Time Frame: 3 months ]

Enrollment: 80
Study Start Date: August 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
HCV (+)
Hemodialysis patients with chronic hepatitis C
HCV (-)
Hemodialysis patients without chronic hepatitis C
Control
Healthy volunteers

Detailed Description:
Hepatitis C virus (HCV) infection is the most common cause of chronic liver disease in the world and also common among chronic hemodialysis (HD) patients. Patients with chronic HCV often have increased liver iron, a condition associated with reduced sustained response to antiviral therapy, more rapid progression to cirrhosis, and development of hepatocellular carcinoma; however, little is known about the mechanism of iron accumulation in the liver. Recently identified hepcidin, a 25-amino acid peptide hormone exclusively synthesized in the liver, is thought to be a key regulator for iron homeostasis and is induced by infection and inflammation. Hepcidin expression is modulated by iron stores, so that it decreases in iron deficiency to facilitate iron absorption while it increases in iron repletion to prevent pathological overload. Interleukin (IL)-6 has been proposed as a major inducer of hepcidin, via direct transcriptional activation of hepatic hepcidin expression by binding to its receptor complex containing gp130 to activate janus kinase (JAK) and activator of transcription 3 (STAT 3).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients on chronic hemodialysis
Criteria

Inclusion Criteria:

  • Chronic hemodialysis patients

Exclusion Criteria:

  • Patients positive for hepatitis B virus surface antigen (HBsAg)
  • Patients previously diagnosed nonrenal cause of anemia other than iron deficiency
  • Patients with an evidence of active or occult bleeding
  • Patients received blood transfusion within the past 4 months
  • Patients with a history of malignancy, end-stage liver disease, or chronic hypoxia
  • Patients with a history of recent hospitalization or infection requiring antibiotics within the past 4 weeks.
  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): NCT01272479


Locations
Turkey
Division of Nephrology, Istanbul Faculty of Medicine
Istanbul, Turkey, 34390
Sponsors and Collaborators
Istanbul University
Investigators
Principal Investigator: Yasar Caliskan MD
  More Information

Publications:
Responsible Party: Istanbul University Scientific Research Projects, Istanbul University
ClinicalTrials.gov Identifier: NCT01272479     History of Changes
Other Study ID Numbers: 1692
First Submitted: January 6, 2011
First Posted: January 7, 2011
Last Update Posted: January 7, 2011
Last Verified: November 2009

Keywords provided by Istanbul University:
hemodialysis
hepatitis C
inflammation
iron stores
prohepcidin

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Inflammation
Hepatitis, Chronic
Hepatitis C, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Hepcidins
Anti-Infective Agents


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