| Outcome Measures: |
Primary: Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined), An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs defined as an AE beginning after first dose of study drug until 28 days after last dose of study drug or existing AEs that worsened after first dose of study drug until the participant's last study visit. Severe AEs defined as incapacitating, inability to perform usual activities. Drug-related TEAEs defined as TEAEs with possible, probable, or definite relationship to study drug. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section., Baseline up to Week 16 (End of Study (EoS])|Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment), Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline was defined as the mean of last 3 available values prior to the first dose., Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing)|Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up), Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline is defined as the mean of last 3 available values prior to the first dose., Baseline, Week 8 (2 Weeks of Follow Up) | Secondary: Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment), Hb response defined as an increase in Hb from baseline by ≥1.0 g/dL (not due to red blood cell transfusion or IV iron supplementation during treatment). The baseline for Hb was defined as the mean of the last 3 available Hb values obtained prior to the first dose., Baseline up to Day 26-29 (EoT), up to Week 8 (2 weeks of follow up), and up to Week 16 (EoS, 4 weeks of follow up)|Plasma Roxadustat Concentration (Part 2), Predose on Days 3 (TIW dose groups) or 4 (BIW dose groups), 8, 15, 22, and 26 (TIW dose groups) or 29 (BIW dose groups)|Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29, Baseline is defined as the last value obtained prior to the first dose., Baseline (Day 1), 1, 2, 3, 4, 6, 8, 12, 18, 24, 48, and 72 hours on Day 26 (TIW Dosing) or Day 29 (BIW Dosing)|Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1, Baseline is defined as the last value obtained prior to the first dose., Baseline, 4, 8, 12, and 24 hours on Day 1
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| Locations: |
Peoria, Arizona, 85381, United States|Tempe, Arizona, 85284, United States|Los Angeles, California, 90095, United States|Mission Viejo, California, 92691, United States|Sacramento, California, 95825, United States|San Diego, California, 92123, United States|Whittier, California, 90603, United States|Arvada, Colorado, 80002, United States|Westminster, Colorado, 80031, United States|Middlebury, Connecticut, 06762, United States|Ocala, Florida, 34471, United States|Panama City, Florida, 32401, United States|Pembroke Pines, Florida, 33028, United States|Tampa, Florida, 33614, United States|Augusta, Georgia, 30901, United States|Chicago, Illinois, 60616, United States|Evergreen Park, Illinois, 60805, United States|Wichita, Kansas, 67214, United States|Louisville, Kentucky, 40202, United States|Baton Rouge, Louisiana, 70809, United States|Shreveport, Louisiana, 71101, United States|Detroit, Michigan, 48236, United States|Lincoln, Nebraska, 68510, United States|Las Vegas, Nevada, 89106, United States|Flushing, New York, 11355, United States|Winston-Salem, North Carolina, 27103, United States|Cleveland, Ohio, 44109, United States|Toledo, Ohio, 43606, United States|Medford, Oregon, 97504, United States|Wynnewood, Pennsylvania, 19096, United States|Columbia, South Carolina, 29203, United States|Orangeburg, South Carolina, 29118, United States|Chattanooga, Tennessee, 37404, United States|Houston, Texas, 77036, United States
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