Lead Sponsor

AMAG Pharmaceuticals, Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•1. Males and females ≥18 years of age
•2. An estimated glomerular filtration rate \<60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis)
•3. Hemoglobin \<11.0 g/deciliter (dL)
•4. Transferrin saturation \<30%
•5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week
•6. Female participants 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

•1. History of allergy to IV iron
•2. Allergy to 2 or more classes of drugs
•3. Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
•4. Hemoglobin ≤7.0 g/dL
•5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period
•6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency)

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