iron deficiency anemia (IDA) MedDRA version: 12.1 Level: LLT Classification code 10022975 Term: Iron deficiency anemia secondary to blood loss (chronic) MedDRA version: 12.1 Level: LLT Classification code 10022976 Term: Iron deficiency anemia secondary to inadequate dietary iron intake
Conditions
Interventions
ferumoxytol Drug Substance
Other descriptive name: polyglucose sorbitol carboxymethylether (PCS) superparamagnetic iron oxide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equa
Sponsors
AMAG Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females =18 years of age 2. Subjects with IDA defined as: a) hemoglobin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of allergy to IV iron 2. Allergy to two or more classes of drugs 3. Subjects on dialysis or with an estimated glomerular filtration rate (eGFR) 600 ng/mL 7. Parenteral iron therapy within 4 weeks prior to screening, oral iron therapy within 2 weeks prior to screening, or red blood cell (RBC)/whole blood transfusion within 2 weeks prior to screening or planned during the study 8. Erythropoiesis-stimulating agent (ESA) therapy initiated, stopped, or dose changed by >20% within 4 weeks prior to screening, or an anticipated ESA dose change of >20% during the study 9. Known causes of anemia other than iron deficiency (eg, hemolysis, vitamin B12 or folate deficiency, etc) 10. Major surgery or invasive intervention within 4 weeks prior to screening, organ transplant within 6 months prior to screening, or any planned surgery or intervention during the course of the study 11. Recent (within 2 months prior to screening) initiation or change in therapy to control bleeding (eg, azathioprine or 6-mercaptopurine for inflammatory bowel disease [IBD], hormonal therapy for abnormal uterine bleeding [AUB]) or expected to change therapy during the study 12. Active clinically significant infection or acute serious medical illness (with the exception of cancer) requiring treatment or intervention within 2 weeks prior to screening 13. Among subjects with cancer (ie, histologic diagnosis of nonhematologic malignancy), an Eastern Cooperative Oncology Group (ECOG) Performance Status of >2 or life expectancy 2 prior courses/regimens of chemotherapy or radiation therapy to >40% of the bone marrow within the previous 2 years, or history of or preparation for bone marrow transplant 14. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an investigational agent not specified by this protocol during the study period 15. Any other clinically significant medical disease or condition (eg, uncontrolled 1. History of allergy to IV iron hypertension) or subject responsibility that, in the Investigator’s opinion, may interfere with a subject’s ability to give informed consent, adhere to the protocol, interfere with assessment of the investigational product, or serve as a contraindication to the subject’s participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the efficacy and safety of a 1.02 g of IV ferumoxytol, administered as 2 doses of 510 mg each, compared with 1.0 g of iron sucrose, administered as 5 doses of 200 mg each for the treatment of IDA.;Secondary Objective: there are no secondary objectives of the trial;Primary end point(s): Proportion of subjects achieving a =2.0 g/dL increase in hemoglobin at any time from Baseline to Week 5 | — |
Countries
France, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Spain, United Kingdom
Outcome results
None listed