EUCTR2009-015630-30-GB进行中（未招募）不适用
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 - FIRST
适应症
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
- 150
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
- •A subject will be eligible for enrollment in the study if all of the following criteria apply:
- •1. Males and females =18 years of age
- •2. An eGFR <60 mL/min or a diagnosis of underlying CKD (eg, nephropathy, nephritis)
- •3. Hemoglobin <11.0 g/dL
- •4. TSAT <30%
- •5. Hemodialysis subjects on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week
- •6. 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
- •7. Subject is capable of understanding and complying with the protocol requirements and available for the duration of the study
- •8. 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject will not be eligible for enrollment in the study if any of the following criteria apply:
- •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 value =7.0 g/dL
- •5. Parenteral iron therapy within 4 weeks prior to screening or oral iron therapy within 2 weeks prior to screening
- •6. Red blood cell (RBC) or whole blood transfusion within 2 weeks prior to screening or planned during the study
- •7. 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. Receiving peritoneal dialysis (PD)
- •9. Subjects not on dialysis for whom initiation of dialysis is considered imminent
- •10. Recent (within 4 weeks of screening) blood loss from causes other than dialysis (eg, gastrointestinal bleeding, recent major surgery, etc)
- •11. 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
- •12. Known causes of anemia other than iron deficiency (eg, hemolysis, vitamin B12 or folate deficiency, etc)
- •13. Active malignancy (except non-melanoma skin cancer or carcinoma in situ that has been excised)
- •14. Acute serious medical illness requiring intervention or therapy within 2 weeks prior to screening (eg, acute liver disease, coronary event)
- •15. Any other clinically significant medical disease or condition (eg, uncontrolled hypertension), or label specific contraindication(s), or responsibility that, in the Investigator’s opinion, may interfere with a subject’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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