Efficacy of Intravenous Iron Administration in Hemodialysis Patients

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298441
• Other study ID #: KU-Neph-05-001
• Status: Completed
• Phase: Phase 4
• First received: February 28, 2006
• Last updated: May 8, 2008
• Start date: June 2005
• Est. completion date: March 2007

Study information

• Verified date: May 2008
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2007
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Chronic Renal Failure
• Hemodialysis
• Iron Deficiency Anemia
• Kidney Failure, Chronic
• Renal Anemia

Intervention

Drug:
• chondroitin sulfate-iron colloid

Locations

Country	Name	City	State
Japan	Midorigaoka Clinic	Arao	Kumamoto
Japan	Kumamoto University Hospital	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin levels at 24 weeks
Primary	oxidized albumin levels at 24 weeks