Iron deficiency anemia (IDA) MedDRA version: 14.0 Level: LLT Classification code 10022976 Term: Iron deficiency anemia secondary to inadequate dietary iron intake System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.0 Level: LLT Classification code 10022975 Term: Iron deficiency anemia secondary to blood loss (chronic) System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
ferumoxytol Drug Substance
Other descriptive name: FERUMOXYTOL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Sponsors
AMAG Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who met all inclusion/exclusion criteria for AMAG-FER-IDA-301, received any study drug, and completed the Week 5 visit within the past 14 days 2. Female subjects of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study 3. Subject is capable of understanding and complying with the protocol requirements and available for the duration of the study 4. Subject has been informed of the investigational nature of this study and has given voluntary written informed consent and, if applicable, Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional, local, and national personal health data protection guidelines Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 640 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
Exclusion criteria: 1. Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301 2. Female subjects who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test 3. Received IV or oral iron since completion of AMAG-FER-IDA-301 4. Major surgery or invasive intervention (with the exception of uncomplicated diagnostic colonoscopy, endoscopy, and tubal ligation)during participation in or since completion of AMAG FER IDA-301 5. Active clinically significant infection or acute serious medical illness (with the exception of cancer) requiring treatment or intervention 6. Received another investigational agent during participation in study AMAG-FER IDA 301 or prior to enrollment in this study 7. Any other clinically significant medical disease or condition (eg, uncontrolled hypertension) or subject responsibility that, in the Investigator’s opinion, may interfere with a subject’s (and/or guardian’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: To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA) over a 6-month period ;Secondary Objective: Not Applicable;Primary end point(s): Mean change in hemoglobin from treatment period (TP) Baseline (defined as the hemoglobin level immediately prior to each ferumoxytol treatment course) to TP Week 5 following the first course of ferumoxytol ;Timepoint(s) of evaluation of this end point: Week 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of subjects with an increase in hemoglobin =2.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol • Proportion of subjects who achieve a hemoglobin =12.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol • Mean change in TSAT from TP Baseline to TP Week 5 following each course of ferumoxytol • Time to hemoglobin increase of =2.0 g/dL or to a hemoglobin level of =12.0 g/dL from TP Baseline to TP Week 5 following each course of ferumoxytol • Mean change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score from TP Baseline to TP Week 5 following each course of ferumoxytol • Proportion of subjects with AUB, cancer, GI disorders, and postpartum anemia, each achieving a =2.0 g/dL rise in hemoglobin at any time from Baseline to TP Week 5 following each course of ferumoxytol • Mean change in hemoglobin from Baseline to TP Week 5 in subjects with AUB, cancer, GI disorders, and postpartum anemia following each course of ferumoxytol ;Timepoint(s) of evaluation of this end point: Week 5 | — |
Countries
Canada, Ecuador, El Salvador, Honduras, India, Latvia, Poland, United States
Contacts
Public ContactRatna Lingamaneni
AMAG Pharmaceuticals, Inc.
Outcome results
None listed