Efficacy of Intravenous Iron Administration in Hemodialysis Patients
Chronic Renal Failure
Iron Deficiency Anemia
Drug: chondroitin sulfate-iron colloid
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of IVIR Frequency on Anemia Correction and Oxidative Stress Formation and in Hemodialysis Patients|
- hemoglobin levels at 24 weeks
- oxidized albumin levels at 24 weeks
|Study Start Date:||June 2005|
|Study Completion Date:||March 2007|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298441
|Arao, Kumamoto, Japan, 864-0033|
|Kumamoto University Hospital|
|Kumamoto, Japan, 860-8556|
|Principal Investigator:||Kenichiro Kitamura, M.D., Ph.D.||Kumamoto University|