Table 2 Key inclusion and exclusion criteria in the Ferumoxytol for Anemia of CKD Trial
Inclusion criteria | Exclusion criteria |
|---|---|
Main study | |
•Males and females aged ≥18 years | •History of allergy to either oral or intravenous iron |
•Patients with iron deficiency anemia defined as hemoglobin <11.5 g/dL (<115.0 g/L) and transferrin saturation <30% | •Female patients who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test |
•Serum ferritin <800 ng/mL (<1798 pmol/L) | •Parenteral iron therapy within 30 days prior to screening or red blood cell/whole blood transfusion within 14 days prior to screening or planned during the study |
•Patients must have been on hemodialysis for ≥3 months prior to screening | •Untreated vitamin B12 or folate deficiency |
•Female patients of childbearing potential who are sexually active must be on an effective method of birth control for ≥1 month prior to screening and agree to remain on birth control until study completion | •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 treatment period |
•Patient is capable of understanding and complying with the protocol requirements and available for the study duration | •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 |
•Provide written informed consent | •Any other clinically significant medical disease or psychiatric disease or condition that, in the investigator’s opinion, may interfere with the patient’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 patient’s participation in the study |
MRI substudy | |
•Same as main study | •Same as main study •Has any contraindication to MRI or otherwise unable to undergo MRI (e.g., pacemaker, recent wound clips, severe claustrophobia, or unable to lay flat for sufficient time to undergo imaging) |
•Baseline cardiac T2*-weighted MRI value <20 msec | |