A Randomized, Open-Label, Active-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Ferumoxytol Compared with Oral Iron for the Treatment of Iron Deficiency Anemia in Pediatric Subjects with Nondialysis-dependent Chronic Kidney Disease
- Conditions
- ondialysis dependent Chronic Kidney DiseaseMedDRA version: 13.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders
- Registration Number
- EUCTR2010-019388-12-RO
- Lead Sponsor
- AMAG Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 144
1. Male or female 6 months to <18 years of age
2. Nondialysis dependent CKD, including kidney transplant recipients
3. Has IDA defined as: a) hemoglobin <11.0 g/dL and b) TSAT <20%
4. 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 the study
5. Subject and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study
6. 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:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. History of allergy to either oral or intravenous (IV) iron
2. Allergy to two or more classes of drugs
3. On hemodialysis or peritoneal dialysis
4. Hemoglobin =7.0 g/dL
5. Serum ferritin level >600 ng/mL
6. Parenteral iron therapy within 4 weeks prior to Screening; oral iron therapy within 2 weeks prior to Screening; or blood transfusion within 2 weeks prior to Screening, or planned during the study
7. 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
8. Known causes of anemia other than iron deficiency (eg, vitamin B12 or folate deficiency, hemolytic anemia, etc)
9. 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
10. Active malignancy within 2 years prior to Screening (except nonmelanoma skin cancer or carcinoma in situ that has been excised)
11. Active clinically significant infection (eg, systemic bacterial infection) or acute serious medical illness requiring treatment or intervention within 2 weeks prior to Screening
12. 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
13. Female subjects who are pregnant or intend to become pregnant, or are breastfeeding, are within 3 months postpartum, or have a positive serum pregnancy test
14. Any other clinically significant medical or psychiatric disease or condition (eg, uncontrolled hypertension, psychosis) 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method