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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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