Efficacy of Intravenous Iron Administration in Hemodialysis Patients

NCT ID: NCT00298441

Last Updated: 2008-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2007-03-31

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.

Conditions

Chronic Renal Failure; Hemodialysis; Renal Anemia; Iron Deficiency Anemia

Keywords

intravenous iron administration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

chondroitin sulfate-iron colloid

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kumamoto University

OTHER

Sponsor Role: lead

Principal Investigators

Kenichiro Kitamura, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kumamoto University

Locations

Midorigaoka Clinic

Arao, Kumamoto, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Countries

Japan

References

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. doi: 10.1111/j.1523-1755.2004.00813.x.

Reference Type: BACKGROUND

PMID: 15253741 (View on PubMed)

Other Identifiers

KU-Neph-05-001

Identifier Type: -

Identifier Source: org_study_id