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 Dialysis dependent Chronic Kidney Disease

AMAG Pharmaceuticals, Inc.0 sites14 target enrollmentJune 17, 2011

Overview

No summary available.

Registry

who.int

Start Date

June 17, 2011

End Date

June 24, 2014

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\.Male or female 6 months to \<18 years of age
•2\.On peritoneal dialysis or hemodialysis for \=3 months prior to Screening
•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 one 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 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 IV iron
•2\.Allergy to two or more classes of drugs
•3\.Hemoglobin \=7\.0 g/dL
•4\.Serum ferritin level \>600 ng/mL
•5\.Parenteral iron therapy within 4 weeks prior to Screening; oral iron therapy within 2 weeks prior to Screening; or RBC or whole blood transfusion within 2 weeks prior to Screening, or planned during the study
•6\.Erythropoiesis\-stimulating agent 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
•7\.Known causes of anemia other than iron deficiency (eg, vitamin B12 or folate deficiency, etc)
•8\.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
•9\.Active malignancy within 2 years (except nonmelanoma skin cancer or carcinoma in situ that has been excised)
•10\.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