EUCTR2010-019388-12-HU进行中（未招募）不适用
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 Nondialysis-dependent Chronic Kidney Disease
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female 6 months to <18 years of age
- •2. Nondialysis dependent CKD, including kidney transplant recipients
- •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 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: 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
排除标准
- •1. History of allergy to either oral or intravenous (IV) iron
- •2. Allergy to two or more classes of drugs
- •3. On hemodialysis or peritoneal dialysis
- •4. Hemoglobin =7.0 g/dL
- •5. Serum ferritin level >600 ng/mL
- •6. Parenteral iron therapy within 4 weeks prior to Screening; oral iron therapy within 2 weeks prior to Screening; or blood transfusion within 2 weeks prior to Screening, or planned during the study
- •7. Erythropoiesis-stimulating agent (ESA) 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
- •8. Known causes of anemia other than iron deficiency (eg, vitamin B12 or folate deficiency, hemolytic anemia, etc)
- •9. 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
- •10. Active malignancy within 2 years prior to Screening (except nonmelanoma skin cancer or carcinoma in situ that has been excised)
- •11. Active clinically significant infection (eg, systemic bacterial infection) or acute serious medical illness requiring treatment or intervention within 2 weeks prior to Screening
- •12. 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
- •13. 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
- •14. 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
研究者
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