Efficacy of Intravenous Iron Administration in Hemodialysis Patients

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: NCT00298441
Recruitment Status : Completed
First Posted : March 2, 2006
Last Update Posted : May 12, 2008
Information provided by:
Kumamoto University

February 28, 2006
March 2, 2006
May 12, 2008
June 2005
May 2006   (Final data collection date for primary outcome measure)
  • hemoglobin levels at 24 weeks
  • oxidized albumin levels at 24 weeks
Same as current
Complete list of historical versions of study NCT00298441 on Archive Site
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Efficacy of Intravenous Iron Administration in Hemodialysis Patients
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Chronic Renal Failure
  • Hemodialysis
  • Renal Anemia
  • Iron Deficiency Anemia
Drug: chondroitin sulfate-iron colloid
Not Provided
Anraku M, Kitamura K, Shinohara A, Adachi M, Suenga A, Maruyama T, Miyanaka K, Miyoshi T, Shiraishi N, Nonoguchi H, Otagiri M, Tomita K. Intravenous iron administration induces oxidation of serum albumin in hemodialysis patients. Kidney Int. 2004 Aug;66(2):841-8. Erratum in: Kidney Int. 2004 Sep;66(3):1304. Suenaga, Ayaka [corrected to Suenga, Ayaka].

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2007
May 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Kumamoto University
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Principal Investigator: Kenichiro Kitamura, M.D., Ph.D. Kumamoto University
Kumamoto University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP