Evaluation of ferumoxytol for the treatment of iron deficiency anemia in pediatric subjects

• Conditions: Chronic Kidney Disease; MedDRA version: 17.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-019387-37-GB
• Lead Sponsor: AMAG Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-08
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
11.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
12.Any other clinically significant medical or psychiatric disease 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified