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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

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
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 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
11.Female subjects who are pregnant or intend to become pregnant, or are breastfeeding, are within three months postpartum, or have a positive serum pregnancy test
12.Any other clinically significant medical disease or condition (eg, uncontrolled hypertension) 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

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