Chronic Renal FailurePhase 4NCT00298441
Efficacy of Intravenous Iron Administration in Hemodialysis Patients
A Phase 4 study testing chondroitin sulfate-iron colloid in people with Chronic Renal Failure and Hemodialysis, run by Kumamoto University at 2 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Renal Failure, Hemodialysis, Renal Anemia
- What is being tested?
- chondroitin sulfate-iron colloid
- How many people
- 50 participants
- Where
- 2 sitesJapan
- Study dates
- Jun 2005to Mar 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic renal failure
- Clinical diagnosis of iron deficiency anemia
- Must be on regular hemodialysis
Who cannot join
- Allergic to intravenous iron administration
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Midorigaoka Clinic
Arao, Kumamoto, 864-0033
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
About this study
Official title: Effect of IVIR Frequency on Anemia Correction and Oxidative Stress Formation and in Hemodialysis Patients
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.
Read the 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.
- Being tested
- chondroitin sulfate-iron colloid
- Keywords
- intravenous iron administration
- Medical subject headings
- Kidney Failure, Chronic, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chondroitin sulfate-iron colloidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin levels at 24 weeks
oxidized albumin levels at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startJun 2005
- Primary completionMay 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Investigators
- Kenichiro Kitamura, M.D., Ph.D., Principal investigator, Kumamoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298441
- Sponsor's protocol ID
- KU-Neph-05-001
- Status last verified
- May 2008
- First submitted
- 28 Feb 2006
- Last updated
- 12 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15253741
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of IVIR Frequency on Anemia Correction and Oxidative Stress Formation and in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00298441
- Acronym / sponsor ID
- KU-Neph-05-001
- Keywords
- intravenous iron administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 2 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of chronic renal failure
- Clinical diagnosis of iron deficiency anemia
- Must be on regular hemodialysis
Key exclusion criteria (1 listed)
- Allergic to intravenous iron administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chondroitin sulfate-iron colloid | Drug | – |
Primary outcome
hemoglobin levels at 24 weeks
oxidized albumin levels at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2008.
- Background: PubMed 15253741Anraku 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenichiro Kitamura, M.D., Ph.D. principal investigator
Kumamoto University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing chondroitin sulfate-iron colloid in people with Chronic Renal Failure and Hemodialysis, run by Kumamoto University at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin levels at 24 weeks. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2008.