Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects with Chronic Kidney Disease - FER-CKD-201

AMAG Pharmaceuticals Inc0 个研究点目标入组 150 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Males and females >=18 years of age
•2.A diagnosis of CKD (eg, nephropathy, nephritis)
•3.Hemodialysis subjects on maintenance dialysis for at least three months prior to screening and currently receiving dialysis three times per week
•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 is capable of understanding and complying with the protocol requirements and is available for the duration of the study
•6.Subject has been informed of the investigational nature of this study and has given voluntary written informed consent and, if applicable, Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional, local, and national personal health data protection guidelines

•1.History of allergy to IV iron
•2.Allergy to 2 or more classes of drugs
•3.Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
•4.Hemoglobin ≤7.0 g/d

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