An Open-Label Extension Study of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Subjects with Chronic Kidney Disease

Phase 1

• Conditions: Chronic Kidney Disease; MedDRA version: 13.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders

• Registration Number: EUCTR2010-019550-40-RO
• Lead Sponsor: AMAG Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-25
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

1. Subjects who have completed participation in study FER CKD 251 or FER CKD-252 within the past 4 weeks
2. Female subjects of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of the study
3. Subject and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study
4. 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:
F.1.2 Adults (18-64 years) yes
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. Experienced a serious adverse event (SAE) related to intravenous (IV) iron therapy in study FER CKD 251 or FER-CKD-252
2. Hemoglobin =7 g/dL
3. Major surgery or invasive intervention within 4 weeks prior to Screening or during the Screening Period
4. Development of an active malignancy during participation in study FER CKD 251 or FER-CKD-252 or prior to enrollment in this study (except nonmelanoma skin cancer or carcinoma in situ that is excisable)
5. Received an investigational agent during participation in study FER CKD 251 or FER-CKD-252 or prior to enrollment in this study, other than as specified by the study protocols
6. Female subjects who are pregnant or intend to become pregnant or have a positive serum or urine pregnancy test
7. Development of any other clinically significant medical or psychiatric disease or condition (eg, uncontrolled hypertension, psychosis) 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