Clinical trial NCT00298441: Efficacy of Intravenous Iron Administration in Hemodialysis Patients
Official title: Effect of IVIR Frequency on Anemia Correction and Oxidative Stress Formation and in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Failure
Hemodialysis
Renal Anemia
Iron Deficiency Anemia
Keywords: intravenous iron administration
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2006-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: hemoglobin levels at 24 weeks
measure: oxidized albumin levels at 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Arao
country: Japan
facility: Midorigaoka Clinic
state: Kumamoto
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
Study officials:
affiliation: Kumamoto University
name: Kenichiro Kitamura, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.