EUCTR2010-018961-50-PL进行中（未招募）不适用
A Phase III, Randomized, Open-label, Active-Controlled Trial Comparing Ferumoxytol with Iron Sucrose for the Treatment of Iron Deficiency Anemia
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
- 600
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. Males and females =18 years of age
- •2. Subjects with IDA defined as:
- •a) hemoglobin <10.0 g/dL
- •b) TSAT <20%
- •3. Subjects who have a history of unsatisfactory oral iron therapy or in whom oral
- •iron cannot be used (includes subjects who remain anemic despite oral iron therapy, have side effects that preclude the use of oral iron therapy, or who cannot otherwise take oral iron)
- •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 participation in the study
- •5. Subject is capable of understanding and complying with the protocol requirements
- •and 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) or patient protection 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
- •1. History of allergy to IV iron
- •2. Allergy to two or more classes of drugs
- •3. Subjects on dialysis or with an estimated glomerular filtration rate (eGFR)
- •<30 mL/min/1.73 square metre
- •4. Female subjects who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
- •5. Hemoglobin =7.0 g/dL
- •6. Serum ferritin >600 ng/mL
- •7. Parenteral iron therapy within 4 weeks prior to screening, oral iron therapy within
- •2 weeks prior to screening, or red blood cell (RBC)/whole blood transfusion
- •within 2 weeks prior to screening or planned during the study
- •8. 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
- •9. Known causes of anemia other than iron deficiency (eg, hemolysis, vitamin B12 or
- •folate deficiency, etc)
- •10. 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
- •11. Recent (within 2 months prior to screening) initiation or change in therapy to
- •control bleeding (eg, azathioprine or 6-mercaptopurine for inflammatory bowel
- •disease [IBD], hormonal therapy for abnormal uterine bleeding [AUB]) or
- •expected to change therapy during the study
- •12. Active clinically significant infection or acute serious medical illness (with the
- •exception of cancer) requiring treatment or intervention within 2 weeks prior to
- •13. Among subjects with cancer (ie, histologic diagnosis of nonhematologic
- •malignancy), an Eastern Cooperative Oncology Group (ECOG) Performance
- •Status of >2 or life expectancy <24 weeks; or >2 prior courses/regimens of
- •chemotherapy or radiation therapy to >40% of the bone marrow within the
- •previous 2 years, or history of or preparation for bone marrow transplant
- •14. 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
- •15. Any other clinically significant medical disease or condition (eg, uncontrolled 1. History of allergy to IV iron hypertension) or subject responsibility that, in the Investigator’s opinion, may interfere with a subject’s ability to give informed consent, 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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