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NCT00583973 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by University of California, Davis.

Completed
Registry status
11
Enrollment target

NCT00583973 is a clinical trial that has completed, run by University of California, Davis. The registered enrollment target is 11 participants.

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The verdict

NCT00583973 has completed, sponsored by University of California, Davis.

COMPLETED
Registry status
11 participants
Enrollment target

Study 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.

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2007-01
Est. Completion 2009-01

Sponsor

University of California, Davis

657 total trials

What the Registry Record Tells You About NCT00583973

The ClinicalTrials.gov registry entry for NCT00583973 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00583973 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00583973 about?

NCT00583973 is a clinical study titled "Effect of Parenteral Iron Therapy on Inflammatory Response and Oxidative Stress Chronic Hemodialysis". 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 h...

What is the current status of trial NCT00583973?

This trial is currently completed. The enrollment target is 11 participants. The study started on 2007-01. Estimated completion is 2009-01.

Who is sponsoring clinical trial NCT00583973?

This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.