| Outcome Measures: |
Primary: Number (%) of Participants With an Hb Response by Week 17, An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL., Up to Week 17 | Secondary: Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25, An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL., Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)|Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25, Baseline is defined as the mean of the last 3 available values predose., Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)|Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28, Participants can have a Hb value reported for more than 1 of the categories (11-12, 11-13, and 10.5-13 g/dL) during the week intervals since these categories are not mutually exclusive., Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)|Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28, Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)|Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25, Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks., Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)|Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28, Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)|Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL, Median time to response was estimated using Kaplan Meier method, Cohort A and B censored at Week 17, Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved., Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)|Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline, Median time to response was estimated using Kaplan Meier method; Cohort A and B censored at Week 17 and Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved., Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F)|Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline, Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)|Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week, Cohorts A and B: Weekly through Week 16 (end of treatment), Week 18 (2 weeks posttreatment), and Week 20 (4 weeks posttreatment); Cohorts C-F: Weekly through Week 24 (end of treatment), Week 26 (2 weeks posttreatment), and Week 28 (4 weeks posttreatment)|Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories, Cohorts A and B: Weekly through Week 16 (end of treatment [EoT]) and Week 20 (Follow up [4 weeks posttreatment]); Cohorts C-F: Weekly through Week 24 (EoT) and Week 28 (Follow up [4 weeks posttreatment])|Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25, The mean percentage of the scheduled weekly Hb values that were \<10.5, \>13, and \>14 g/dL during Weeks 13-17 and 18-25 is presented., Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only)|Number (%) of Participants Requiring Rescue Therapy, Rescue treatment included recombinant erythropoiesis-stimulating agent (ESA), red blood cell transfusion (in the absence of a known bleeding episode or surgical blood loss), or intravenous (IV) Iron, Baseline up to Week 28 (end of study)|Number (%) of Participants Requiring Therapeutic Phlebotomy, Baseline up to Week 28 (end of study)|Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy, Baseline up to Week 28 (end of study)|Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24, Dose changes include dose reductions, dose increases, and dose holds., Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only)|Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL), Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)|Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL), Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)|Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24, Baseline was defined as the mean of the last 3 available values predose., Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment)
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| Locations: |
Mobile, Alabama, United States|Pine Bluff, Arkansas, United States|Azusa, California, United States|Chula Vista, California, United States|Downey, California, United States|Northridge, California, United States|Paramount, California, United States|Riverside, California, United States|Whittier, California, United States|Yuba City, California, United States|Fort Lauderdale, Florida, United States|Lauderdale Lakes, Florida, United States|Pembroke Pines, Florida, United States|Tampa, Florida, United States|Augusta, Georgia, United States|Meridian, Idaho, United States|Wichita, Kansas, United States|Baton Rouge, Louisiana, United States|Shreveport, Louisiana, United States|Bethesda, Maryland, United States|Detroit, Michigan, United States|Lincoln, Nebraska, United States|Mount Laurel, New Jersey, United States|Mineola, New York, United States|New York, New York, United States|Asheville, North Carolina, United States|Raleigh, North Carolina, United States|Canton, Ohio, United States|Orangeburg, South Carolina, United States|Knoxville, Tennessee, United States|Arlington, Texas, United States|Fort Worth, Texas, United States|Houston, Texas, United States|San Antonio, Texas, United States|Fairfax, Virginia, United States|Caguas, Puerto Rico|Ponce, Puerto Rico|San Juan, Puerto Rico
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