Trial record 14 of 242 for:
iron-deficiency anemia
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia
This study has been completed.
Sponsor:
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01114139
First received: April 29, 2010
Last updated: May 29, 2013
Last verified: May 2013
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Purpose
To evaluate the efficacy and safety of IV ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).
| Condition | Intervention | Phase |
|---|---|---|
|
Iron Deficiency Anemia |
Drug: Ferumoxytol Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia |
Resource links provided by NLM:
Further study details as provided by AMAG Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Hemoglobin changes [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient reported outcomes [ Designated as safety issue: No ]
| Enrollment: | 812 |
| Study Start Date: | June 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ferumoxytol
Intravenous (IV) iron
|
Drug: Ferumoxytol
IV Ferumoxytol
Other Name: Feraheme
|
|
Placebo Comparator: Placebo
Normal saline
|
Other: Placebo
IV Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria include:
- Males and females ≥18 years of age
- Subjects with IDA
- Subjects who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
- Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study
Key Exclusion Criteria include:
- History of allergy to IV iron
- Allergy to two or more classes of drugs
- Subjects on dialysis or with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- Female subjects who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
- Hemoglobin ≤7.0 g/dL
- Serum ferritin >600 ng/mL
Contacts and Locations More Information
No publications provided
| Responsible Party: | AMAG Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01114139 History of Changes |
| Other Study ID Numbers: | AMAG-FER-IDA-301 |
| Study First Received: | April 29, 2010 |
| Last Updated: | May 29, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Hungary: Ministry of Health, Social and Family Affairs India: Central Drugs Standard Control Organization Latvia: State Agency of Medicines Poland: Ministry of Health |
Keywords provided by AMAG Pharmaceuticals, Inc.:
|
Iron deficiency anemia Feraheme ferumoxytol AUB |
cancer GI disorders postpartum anemia The treatment of iron deficiency anemia (IDA) |
Additional relevant MeSH terms:
|
Anemia Anemia, Iron-Deficiency Anemia, Hypochromic Deficiency Diseases Hematologic Diseases Malnutrition Nutrition Disorders Iron Metabolism Disorders Metabolic Diseases Ferumoxytol |
Iron Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013