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Effect of Parenteral Iron Therapy on Inflammatory Response and Oxidative Stress Chronic Hemodialysis

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. Identifier: NCT00583973
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : June 21, 2017
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

Parenteral iron therapy is now commonly administered to dialysis patients with the majority of patients receiving this therapy as part of the treatment for their anemia. Although intravenous iron has improved clinical response to recombinant erythropoietin, there is a concern that iron therapy may have deleterious effects in Chronic Kidney Disease (CKD) patients. Iron can damage tissues by catalyzing the conversion of hydrogen peroxide to free-radical ions that attack cellular proteins, DNA and membranes as part of oxidative stress. Numerous in vitro studies have shown tissue toxicity from iron and increased infectious potential. Oxidative stress can also lead to activation of the systemic inflammatory response with the release of a number of key cytokines and growth factors. There is now a link between inflammation, oxidative stress and acceleration of vascular disease in both patients with normal as well as reduced renal function. In a study comparing normal versus low hematocrit levels in hemodialysis patients, mortality was higher in the normal hematocrit group. The major difference between the two groups has been attributed to the fact that patients in the normal hematocrit group received significantly more iron than the patients with low hematocrit. There was a 2.4 fold greater mortality rate in patients receiving parenteral iron.

The effect of parenteral iron administration on activation of the systemic inflammatory response in hemodialysis patients has not been evaluated. The purpose of this study is to measure a number of key cytokines, inflammatory and oxidative stress markers in hemodialysis patients receiving iron repletion therapy as part of their standard care.

Condition or disease
Hemodialysis Chronic Kidney Disease Inflammation

Detailed Description:

Study Design

Patients who have been prescribed iron repletion therapy (100 mg IV every dialysis treatment for ten treatments) by their primary nephrologist will be recruited for the study. Baseline blood samples will be obtained before and after each dialysis treatment for two dialysis treatments prior to the administration of iron. On the day of dialysis that iron therapy is started, blood samples will be obtained before and after the dialysis treatment via the patient's vascular access. This procedure will be repeated each dialysis treatment for the ten sessions during which the patient is receiving intravenous iron. Subsequently, pre-dialysis blood samples will be obtained every week for four weeks after the administration of intravenous iron has been completed

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Parenteral Iron Therapy on the Systemic Inflammatory Response and Oxidative Stress in Chronic Hemodialysis Patients
Study Start Date : January 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Iron

Chronic hemodialysis patients

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic hemodialysis patients--stage V CKD

Inclusion Criteria:

  • Hemodialysis patients age 18 or greater who are prescribed parenteral iron by their primary nephrologist

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 identifier (NCT number): NCT00583973

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United States, California
Dialysis Clinics Inc
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Dialysis Clinic, Inc.
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Principal Investigator: Burl R Don, MD University of California, Davis
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Responsible Party: University of California, Davis Identifier: NCT00583973    
Other Study ID Numbers: 200614206
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency