Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents

Korábbi kezelés

• Treatment with an erythropoiesis-stimulating agents (ESA) within 8 weeks prior to Screening
• Active malignancy or treatment for malignancy within the past 2 years prior to Screening

Más betegség

• Active bleeding or recent clinically significant blood loss
• History of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
• Uncontrolled hypertension
• Known hypersensitivity to vadadustat or any excipients in vadadustat tablet

Laborértékek

• Serum albumin level <2.5 g/dL

Egyéb

• Anemia due to a cause other than CKD
• Red Blood Cells transfusion within 4 weeks
• Evidence of iron overload or diagnosis of hemochromatosis

• Diagnosis of anemia of chronic kidney disease (CKD)
• Diagnosis of non-dialysis-dependent (NDD) CKD with an estimated glomerular filtration rate of greater than (>) 10 and less than (<) 60 milliliters/minute/1.73 meters\^2 (mL/min/1.73 m\^2 ) or diagnosis of dialysis dependent (DD) CKD
• Mean screening hemoglobin (Hb) <10.0 grams/deciliters (g/dL)
• Transferrin Saturation ≥ 20%