EUCTR2010-022133-28-GB进行中（未招募）1 期
Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, with MRI Substudy, of Repeated Doses of Ferumoxytol Compared with Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA) in Chronic Kidney Disease (CKD) Patients on Hemodialysis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 293
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
入选标准
- •1. Males and females =18 years of age
- •2. Subjects with IDA defined as:
- •a) hemoglobin <11.5 g/dL; and
- •b) transferrin saturation (TSAT) <30%
- •3. Serum ferritin <800 ng/mL
- •4. Subjects must have been on hemodialysis for at least 3 months prior to Screening
- •5. 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
- •6. Subject is capable of understanding and complying with the protocol requirements and available for the duration of the study
- •7. 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
- •Are the trial subjects under 18? no
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Main Study:
- •1. History of allergy to either oral or IV iron
- •2. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
- •3. Parenteral iron therapy within 30 days prior to Screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to Screening or planned during the study
- •4. Untreated vitamin B12 or folate deficiency
- •5. Erythropoiesis-stimulating agent (ESA) therapy initiated, stopped, or dose changed by >20% within 30 days prior to Screening, or an anticipated ESA dose change of >20% during the initial TP
- •6. Received an investigational agent within 30 days prior to Screening, or planned receipt of an investigational agent not specified by this protocol during the study period
- •7. Any other clinically significant medical disease or psychiatric disease or condition (eg, active malignancy, uncontrolled hypertension, acute medical illness/infection, psychosis) or subject responsibility that, in the Investigator’s opinion, may interfere with the subject’s ability to give informed consent or adhere to the protocol, interfere with assessment of the study agent, or serve as a contraindication to the subject’s participation in the study
- •MRI Substudy:
- •Additional exclusion criteria for subjects in the MRI Substudy include:
- •1. Has any contraindication to MR imaging, or otherwise unable to undergo MRI (e.g., pacemaker, recent wound clips, severe claustrophobia, unable to lay flat for sufficient time to undergo imaging)
- •2. Baseline cardiac T2* value < 20 ms
研究者
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