Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
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| ClinicalTrials.gov Identifier: NCT00233597 |
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Recruitment Status :
Completed
First Posted : October 6, 2005
Last Update Posted : April 4, 2022
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Sponsor:
AMAG Pharmaceuticals, Inc.
Information provided by:
AMAG Pharmaceuticals, Inc.
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Brief Summary:
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anemia | Drug: ferumoxytol or oral iron | Phase 3 |
This study will evaluate the efficacy and safety of intravenous (IV) iron (ferumoxytol) as compared to oral iron in the treatment of anemia in hemodialysis patients receiving erythropoietin. Patients are randomized to receive either two doses of 510 mg of intravenous ferumoxytol in sequential dialysis sessions or 200 mg oral elemental iron daily for three weeks.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 230 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- The mean change in hemoglobin from baseline.
Secondary Outcome Measures :
- Change in iron indices.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients ≥18 years.
- Chronic hemodialysis.
- Stable supplemental EPO therapy.
- Baseline hemoglobin of ≤ 11.5 g/dl.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
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
Locations
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Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
Additional Information:
Publications of Results:
Other Publications:
Publications of Results:
Other Publications:
| ClinicalTrials.gov Identifier: | NCT00233597 |
| Other Study ID Numbers: |
62745-5 |
| First Posted: | October 6, 2005 Key Record Dates |
| Last Update Posted: | April 4, 2022 |
| Last Verified: | April 2022 |
Keywords provided by AMAG Pharmaceuticals, Inc.:
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anemia iron |
Additional relevant MeSH terms:
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Anemia Hematologic Diseases Ferrosoferric Oxide |
Hematinics Parenteral Nutrition Solutions Pharmaceutical Solutions |