Efficacy of Intravenous Iron Administration in Hemodialysis Patients

Phase 4

Completed

• Conditions: Chronic Renal Failure; Hemodialysis; Renal Anemia; Iron Deficiency Anemia

• Registration Number: NCT00298441
• Lead Sponsor: Kumamoto University

Brief Summary

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.

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-02-28
• Study First Submitted QC: 2006-02-28
• Study First Posted: 2006-03-02
• Primary Completion: 2006-05
• Study Completion: 2007-03
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-08
• Last Update Posted: 2008-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
hemoglobin levels at 24 weeks
oxidized albumin levels at 24 weeks

Trial Locations

Locations (2)

Kumamoto University Hospital; 🇯🇵 Kumamoto, Japan

Midorigaoka Clinic; 🇯🇵 Arao, Kumamoto, Japan