| Outcome Measures: |
Primary: Change From Baseline in Hb Over Time, Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. The specific duration over which the participants were assessed was identified as "over time" for the endpoint in the study protocol. Therefore, to be consistent with the endpoint in the study protocol, an individual timepoint was not identified for this primary outcome measure., Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384 | Secondary: Number of Participants With Hb ≥10 g/dL, Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting., Baseline up to Week 384|Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA]), Baseline up to Week 385|Mean Weekly Dose of Study Drug Over Time, Weekly dose amount was the actual total dose amounts within a week, windowed by 7-day period from Day 1. The mean weekly dose is presented for selected time periods based on timepoints reported in Outcome Measures 1 and 2., Baseline up to Week 384|Number of Participants With Dose Adjustments up to Week 52, Dose adjustments include dose increases, dose interruptions, and dose reductions., Baseline up to Week 52|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs, 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 were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. 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 385
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| Locations: |
APEX Research, Riverside, California, 92505, United States|Greenbelt, Maryland, 20770, United States|Mountain Kidney & HTN Associates, PA, Asheville, North Carolina, 28801, United States|Arlington Nephrology, Arlington, Texas, 76015, United States|Consolidated Medical Plaza, Caguas, 00725, Puerto Rico|CAIMED School of Medicine, Ponce, 00716, Puerto Rico|San Juan, 00918, Puerto Rico
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