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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Dialysis Clinic, Inc.
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00583973
First received: December 22, 2007
Last updated: December 31, 2007
Last verified: December 2007
  Purpose

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
Hemodialysis
Chronic Kidney Disease
Inflammation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 20
Study Start Date: January 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Chronic hemodialysis patients

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic hemodialysis patients--stage V CKD

Criteria

Inclusion Criteria:

  • Hemodialysis patients age 18 or greater who are prescribed parenteral iron by their primary nephrologist
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583973

Contacts
Contact: Burl R Don, MD 916-734-7961 br.don@ucdmc.ucdavis.edu

Locations
United States, California
Dialysis Clinics Inc Recruiting
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Dialysis Clinic, Inc.
Investigators
Principal Investigator: Burl R Don, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Burl R. Don, MD, University of California Davis
ClinicalTrials.gov Identifier: NCT00583973     History of Changes
Other Study ID Numbers: 200614206-2
Study First Received: December 22, 2007
Last Updated: December 31, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Kidney Diseases
Renal Insufficiency, Chronic
Pathologic Processes
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014