Iron deficiency anemia in subjects with Chronic kidney disease MedDRA version: 12.1 Level: LLT Classification code 10022974 Term: Iron deficiency anemia
Conditions
Interventions
Product Name: Ferumoxytol
Product Code: N/A
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Ferumoxytol
CAS Number: 722492-56-0
Other descriptive name: Ferumoxytol Drug Substance
Concen
Sponsors
AMAG Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for enrollment in the study if all of the following criteria apply: 1. Males and females =18 years of age 2. An eGFR =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for enrollment in the study if any of the following criteria apply: 1. History of allergy to IV iron 2. Allergy to 2 or more classes of drugs 3. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test 4. Hemoglobin value =7.0 g/dL 5. Parenteral iron therapy within 4 weeks prior to screening or oral iron therapy within 2 weeks prior to screening 6. Red blood cell (RBC) or whole blood transfusion within 2 weeks prior to screening or planned during the study 7. 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 8. Receiving peritoneal dialysis (PD) 9. Subjects not on dialysis for whom initiation of dialysis is considered imminent 10. Recent (within 4 weeks of screening) blood loss from causes other than dialysis (eg, gastrointestinal bleeding, recent major surgery, etc) 11. 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 12. Known causes of anemia other than iron deficiency (eg, hemolysis, vitamin B12 or folate deficiency, etc) 13. Active malignancy (except non-melanoma skin cancer or carcinoma in situ that has been excised) 14. Acute serious medical illness requiring intervention or therapy within 2 weeks prior to screening (eg, acute liver disease, coronary event) 15. Any other clinically significant medical disease or condition (eg, uncontrolled hypertension), or label specific contraindication(s), or responsibility that, in the Investigator’s opinion, may interfere with a subject’s ability to 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 the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in subjects with chronic kidney disease (CKD) -To evaluate the safety of a 1.02 g course of IV ferumoxytol compared to 1.0 g IV iron sucrose;Secondary Objective: -To evaluate the efficacy of ferumoxytol as compared to iron sucrose by assessing the mean change in hemoglobin from Baseline to Week 5 ;Primary end point(s): Safety Endpoints: • AEs of special interest (hypotension, hypersensitivity), SAEs, severe AEs, and AEs leading so study drug discontinuation • All AEs • Vital signs (blood pressure, heart rate, respiration rate, and body temperature) • Physical examination findings • Routine laboratory parameters (hematology, serum chemistry, iron panel, and urinalysis) Efficacy Endpoints • Mean change in hemoglobin from Baseline to Week 5 • Proportion of subjects with an increase in hemoglobin =1.0 g/dL during the period from Baseline to Week 5 Exploratory Endpoints • Health care utilization, including hospitalizations, procedures, and outpatient visits | — |
Countries
Belgium, Germany, United Kingdom
Outcome results
None listed