Efficacy of Intravenous Iron Administration in Hemodialysis Patients

May 8, 2008 updated by: Kumamoto University

Effect of IVIR Frequency on Anemia Correction and Oxidative Stress Formation and in Hemodialysis Patients

The purpose of this study is to determine whether the frequency of intravenous iron administration has an effect on anemia correction and oxidative stress formation in hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In patients who are on chronic hemodialysis (HD), anemia is a major complication and is associated with poor clinical outcomes. Consequently, management of anemia by recombinant erythropoietin is reported consistently to improve outcome measures in HD patients. Because iron is essential for hemoglobin formation, as is erythropoietin, most patients routinely receive iron intravenously (IVIR) for anemia correction. Although IVIR has been shown to improve both survival and quality of life of HD patients, it has been suggested that IVIR may enhance the generation of hydroxyl radicals in the body through the inflammation process and the Fenton reaction. Previously we demonstrated that that serum albumin is highly oxidized in HD patients and that IVIR on these patients significantly increased the oxidation status of albumin.

In 2004, the committee on the guidelines of the Japanese Society for Dialysis Therapy (JSDT) published the original Japanese "Guidelines for Renal Anemia in Chronic Hemodialysis Patients". In the JSDT guidelines 2004, the committee recommended two IVIR schedules for iron deficient patients; 1) administer 40 mg of IV iron at the end of dialysis session 3 times a week for 4 weeks (total 520 mg of iron), 2) administer 40 mg of IV iron at the end of dialysis session once a week for 3 months (total 520 mg of iron). Both administration schedules are effective for the correction of iron deficiency and consequently for the amelioration of anemia. However, the effect of IVIR frequency (three times a week vs. once a week) on the oxidative stress formation has not been investigated before.

Comparison: the two IVIR schedules recommended by the JSDT guideline 2004 will be compared by measuring both hemoglobin and oxidized albumin in chronic HD patients.

Study Type

Interventional

Enrollment

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
    • Kumamoto
      • Arao, Kumamoto, Japan, 864-0033
        • Midorigaoka Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of chronic renal failure
  • Clinical diagnosis of iron deficiency anemia
  • Must be on regular hemodialysis

Exclusion Criteria:

  • Allergic to intravenous iron administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
hemoglobin levels at 24 weeks
oxidized albumin levels at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kumamoto University

Investigators

  • Principal Investigator: Kenichiro Kitamura, M.D., Ph.D., Kumamoto University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (ACTUAL)

May 1, 2006

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

February 28, 2006

First Submitted That Met QC Criteria

February 28, 2006

First Posted (ESTIMATE)

March 2, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2008

Last Update Submitted That Met QC Criteria

May 8, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KU-Neph-05-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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