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

AMAG Pharmaceuticals, Inc.0 sites144 target enrollmentAugust 26, 2010

Overview

No summary available.

Registry

who.int

Start Date

August 26, 2010

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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: 144
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.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)