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Efficacy of Intravenous Iron Administration in Hemodialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298441
First Posted: March 2, 2006
Last Update Posted: May 12, 2008
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:
Kumamoto University
  Purpose
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.

Condition Intervention Phase
Chronic Renal Failure Hemodialysis Renal Anemia Iron Deficiency Anemia Drug: chondroitin sulfate-iron colloid Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of IVIR Frequency on Anemia Correction and Oxidative Stress Formation and in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • hemoglobin levels at 24 weeks
  • oxidized albumin levels at 24 weeks

Estimated Enrollment: 50
Study Start Date: June 2005
Study Completion Date: March 2007
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT00298441


Locations
Japan
Midorigaoka Clinic
Arao, Kumamoto, Japan, 864-0033
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
Investigators
Principal Investigator: Kenichiro Kitamura, M.D., Ph.D. Kumamoto University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00298441     History of Changes
Other Study ID Numbers: KU-Neph-05-001
First Submitted: February 28, 2006
First Posted: March 2, 2006
Last Update Posted: May 12, 2008
Last Verified: May 2008

Keywords provided by Kumamoto University:
intravenous iron administration

Additional relevant MeSH terms:
Anemia
Renal Insufficiency
Anemia, Iron-Deficiency
Kidney Failure, Chronic
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs