Chronic Kidney Disease MedDRA version: 17.0 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 100000004857
Conditions
Interventions
Trade Name: Feraheme (TM)
Product Name: ferumoxytol
Pharmaceutical Form: Solution for injection
CAS Number: 722492-56-0
Current Sponsor code: 7228
ferumoxytol drug product
Other descriptive name: polyglucose sorbitol carboxymethylether (PSC) superparamagnetic iron oxide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
AMAG Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have completed participation in study FER CKD 251 or FER CKD-252 within the past 4 weeks 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 the study 3. Subject and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study 4. Subject and/or legal guardian has been informed of the investigational nature of this study and has given voluntary written informed consent, and, if appropriate, child/adolescent has provided ‘assent’ and Health Insurance Portability and Accountability Act (HIPAA) or patient protection authorization in accordance with institutional, local, and national personal health data protection guidelines Are the trial subjects under 18? yes Number of subjects for this age range: 235 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Experienced a serious adverse event (SAE) related to intravenous (IV) iron therapy in study FER CKD 251 or FER-CKD-252 2. Hemoglobin =7 g/dL 3. Major surgery or invasive intervention within 4 weeks prior to Screening or during the Screening Period 4. Development of an active malignancy during participation in study FER CKD 251 or FER-CKD-252 or prior to enrollment in this study (except nonmelanoma skin cancer or carcinoma in situ that is excisable) 5. Received an investigational agent during participation in study FER CKD 251 or FER-CKD-252 or prior to enrollment in this study, other than as specified by the study protocols 6. Received a non-study-specified IV iron product during or after participation in study FER-CKD-251 or FER-CKD-252 7. Receiving oral iron therapy at the time of screening´ 8. Femal subjects who are pregnant or intend to become pregnant or have a positive serum or urine pregnancy test. 9. Development of any other clinically significant medication or psychiatric desease or condition or subject responsibility that, in the Investigator's opinion, may interfere with a subject's (and/or legal guardian'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
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of subjects with an increase in hemoglobin =1.0 g/dL during the period from Baseline; Proportion of subjects with an increase in hemoglobin to =12.0 g/dL during the period from Baseline; Mean change in TSAT from Baseline; Time to an increase in hemoglobin of =1.0 g/dL from Baseline; Proportion of subjects requiring initiation of ESA or >20% increase in dose during the study; Proportion of subjects receiving blood transfusions during the study; Mean change in other markers of iron stores (eg, serum ferritin and serum iron) from Baseline; Frequency of treatment with ferumoxytol ;Timepoint(s) of evaluation of this end point: Week 5 and 7 post initial dose | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with ferumoxytol. ;Secondary Objective: - To assess the pattern of recurrence of IDA.;Primary end point(s): PRIMARY ENDPOINT: • Mean change in hemoglobin from Baseline to Week 5 following the first course of ferumoxytol ADDITIONAL EFFICACY ENDPOINTS: • Mean change in hemoglobin from Baseline to Week 7 following the first course of ferumoxytol • Proportion of subjects with an increase in hemoglobin =1.0 g/dL during the period from Baseline to Week 5 and Week 7 following each course of ferumoxytol • Proportion of subjects with an increase in hemoglobin to =12.0 g/dL during the period from Baseline to Week 5 and Week 7 following each course of ferumoxytol • Mean change in TSAT from Baseline to Week 5 and Week 7 following the first course of ferumoxytol • Proportion of subjects requiring initiation of ESA or >20% increase in dose during the study • Proportion of subjects receiving blood transfusions during the study • Mean change in other markers of iron stores (eg, serum ferritin and serum iron) from Baseline to Week 5 and Week 7 following the first course of ferumoxytol • Frequency of treatment with ferumoxytol Time to retreatment with ferumoxytol or other anemie treatment. Additional analyses of efficacy endpoints will also be performed based on age cohort, CKD status (stage of CKD, dialysis modality, transplant status), ESA use, and treatment course (first vs subsequent courses of treatment). SAFETY ENDPOINTS • Adverse events of special interest (AESI) (hypotension and hypersensitivity) • SAEs • Severe AEs • Cardiovascular AEs (myocardial infarction, heart failure, moderate to severe hypertension, and hospitalization due to any cardiovascular cause) • AEs leading to study drug discontinuation • All AEs, vital signs (blood pressure, heart rate, respiration rate) and body temperature, and routine laboratory parameters (hematology, chemistry and iron panel) | — |
Countries
Bulgaria, France, Germany, Hungary, Italy, Lithuania, Mexico, Peru, Poland, Romania, Russian Federation, Spain, United Kingdom, United States
Contacts
Public Contactpediatric information
AMAG Europe Limited
Outcome results
None listed