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 Chronic Kidney Disease

AMAG Pharmaceuticals, Inc.0 sites288 target enrollmentOctober 8, 2010

Overview

No summary available.

Registry

who.int

Start Date

October 8, 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\.CKD nondialysis subjects (including kidney transplant recipients) or dialysis dependent subjects who are on peritoneal dialysis or stable hemodialysis prior to Screening
•3\.Has IDA defined as: a) hemoglobin \<12\.0 g/dL and b) with either TSAT \<40% or ferritin \<100 ng/mL
•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: 288
•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\.Hemoglobin \=7\.0 g/dL
•3\.Serum ferritin level \>600 ng/mL
•4\.Parenteral iron therapy within 4 weeks prior to Day 1 Dosing; oral iron therapy at Screening; or blood transfusion within 4 weeks prior to Day 1 Dosing or planned at the time of Screening
•5\.Erythropoiesis\-stimulating agent (ESA) therapy initiated, stopped or dose changed by \>20% within 4 weeks prior to Screening, or anticipated ESA dose change of \>20% during the study
•6\.Known causes of anemia other than iron deficiency (eg, vitamin B12 or folate deficiency, hemolytic anemia, etc)
•7\.Major surgery or invasive intervention within 4 weeks prior to Screening, or any planned surgery or intervention during the course of the study
•8\.Active malignancy within 2 years prior to Screening (except nonmelanoma skin cancer or carcinoma in situ that has been excised)
•9\.Active clinically significant infection (eg, systemic bacterial infection) or acute serious medical illness requiring treatment or intervention within 2 weeks prior to Screening
•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