Efficacy of Intravenous Iron Administration in Hemodialysis Patients
Primary Purpose
Chronic Renal Failure, Hemodialysis, Renal Anemia
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
chondroitin sulfate-iron colloid
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Failure focused on measuring intravenous iron administration
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
Sites / Locations
- Midorigaoka Clinic
- Kumamoto University Hospital
Outcomes
Primary Outcome Measures
hemoglobin levels at 24 weeks
oxidized albumin levels at 24 weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00298441
Brief Title
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
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kumamoto University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure, Hemodialysis, Renal Anemia, Iron Deficiency Anemia
Keywords
intravenous iron administration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
chondroitin sulfate-iron colloid
Primary Outcome Measure Information:
Title
hemoglobin levels at 24 weeks
Title
oxidized albumin levels at 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenichiro Kitamura, M.D., Ph.D.
Organizational Affiliation
Kumamoto University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Midorigaoka Clinic
City
Arao
State/Province
Kumamoto
ZIP/Postal Code
864-0033
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
15253741
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. Erratum In: Kidney Int. 2004 Sep;66(3):1304. Suenaga, Ayaka [corrected to Suenga, Ayaka].
Results Reference
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Efficacy of Intravenous Iron Administration in Hemodialysis Patients
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