Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT00233597|
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : April 4, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: ferumoxytol or oral iron||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy|
|Study Start Date :||August 2004|
|Actual Study Completion Date :||March 2007|
- The mean change in hemoglobin from baseline.
- Change in iron indices.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or female patients ≥18 years.
- Chronic hemodialysis.
- Stable supplemental EPO therapy.
- Baseline hemoglobin of ≤ 11.5 g/dl.
- Women who are pregnant or who are breast feeding.
- Received another investigational drug or device within 30 days.
- Recent parenteral or oral iron therapy.
- Patients with active GI bleeding or acute bleeding within 4 weeks. Patients that have other causes of anemia.
- Major surgery within 30 days or anticipated or planned surgery during the study.
- Patients with active infections.
- Recent blood transfusions.
- Patients with known allergies to iron products.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233597
Publications of Results:
|Other Study ID Numbers:||
|First Posted:||October 6, 2005 Key Record Dates|
|Last Update Posted:||April 4, 2022|
|Last Verified:||April 2022|
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