Patients
CKD, active hepatitis, anemia, infection, human immunodeficiency virus, active infection
HUMAN IMMUNODEFICIENCY VIRUS, HEMOCHROMATOSIS, IRON ACCUMULATION DISORDERS, POLAND, ANEMIA, INFECTION, IRON DEFICIENCY, DISEASES OF THE LIVER, IRON OVERLOAD
Boys and girls eligible for enrollment at study sites in Poland were 1–17 years of age and those in Russia were 6–17 years of age. At screening, eligible patients had a hemoglobin concentration <11 g/dL and a transferrin saturation (TSAT) <20%. Therapy with an erythropoietin-stimulating agent was permitted, provided that the dose had been stable for more than 8 weeks prior to screening and that no changes in the dose or product were anticipated for the duration of the trial.Patients were excluded with a ferritin level >300 ng/mL at screening, with a body mass index (BMI) ≤5th percentile for age, or, for individuals who were enrolled while 1 year of age, with body weight <12 kg. Other exclusion criteria included active infection; anemia for reasons other than iron deficiency; receipt of immunosuppressive therapy, other than steroid therapy, that could exacerbate anemia; receipt of IV iron and/or a blood transfusion within 4 weeks prior to screening; history of acquired iron overload, hemochromatosis, or other iron accumulation disorder; severe diseases of the liver or the hematopoietic or cardiovascular system; CKD treated with hemodialysis; and/or evidence of infection with human immunodeficiency virus, or hepatitis B or C viruses with evidence of active hepatitis.