Efficacy of Intravenous Iron Administration in Hemodialysis Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Renal Failure Hemodialysis Renal Anemia Iron Deficiency Anemia |
Drug: chondroitin sulfate-iron colloid |
Phase 4 |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 50 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Japan | |
| Midorigaoka Clinic | |
| Arao, Kumamoto, Japan, 864-0033 | |
| Kumamoto University Hospital | |
| Kumamoto, Japan, 860-8556 | |
| Principal Investigator: | Kenichiro Kitamura, M.D., Ph.D. | Kumamoto University |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00298441 History of Changes |
| Other Study ID Numbers: | KU-Neph-05-001 |
| Study First Received: | February 28, 2006 |
| Last Updated: | May 8, 2008 |
| Health Authority: | Japan: Institutional Review Board |
Keywords provided by Kumamoto University:
|
intravenous iron administration |
Additional relevant MeSH terms:
|
Anemia Kidney Failure, Chronic Renal Insufficiency Deficiency Diseases Anemia, Iron-Deficiency Hematologic Diseases Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Malnutrition |
Nutrition Disorders Anemia, Hypochromic Iron Metabolism Disorders Metabolic Diseases Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013