| Outcome Measures: |
Primary: Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only, Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. Last observation carried forward (LOCF) method was used to impute missing values., Week 7|Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks, Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values., Week 7|Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks, The average of the mean Hb values that were above 11 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values., Weeks 17, 18, 19, and 20 | Secondary: Number of Participants With a Mean of Hb Within 11-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks), The average of the mean Hb values that were within 11-13 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values., Weeks 17, 18, 19, and 20|Number of Participants With a Mean of Hb Within 10-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks), The average of the mean Hb values that were within 10-13 g/dL at Weeks 17, 18, 19, and 20 are presented. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. LOCF method was used to impute missing values., Weeks 17, 18, 19, and 20|Change From Baseline in Hb at Week 7 for Participants Treated for at Least 6 Weeks, Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values., Baseline, Week 7|Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks, Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values., Baseline, Weeks 8, 10, 12, 14, 17, 19, and 20|Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only, Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants., Baseline up to Week 6|Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks, Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants., Baseline up to Week 19|Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for At Least 6 Weeks, Week 7|Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for 19 Weeks, Week 7|Number of Participants Treated for 6 Weeks Only Whose Hb Levels at Week 7 Were Greater Than Their Baseline Level, Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants., Week 7|Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level, Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants., Weeks 8, 10, 12, 14, 17, 19, and 20|Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for at Least 6 Weeks, Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron., Baseline up to Week 6|Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for 19-Weeks, Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron., Baseline up to Week 19|Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for at Least 6-Weeks, Baseline up to Week 6|Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for 19-Weeks, Baseline up to Week 19|Rate of Change in Hb Levels, Measured by Regression Slopes of the Hb Values During Treatment up to Week 6, The rate of rise was computed as the slope of the regression line of change in Hb level (in g/dL) vs. time (in weeks) using Random Coefficient Model. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants., Baseline up to Week 6|Trough Plasma Concentration of Roxadustat and Epoetin Alfa, Predose, 4, 8, 12, 24, 48, and 72 hours postdose at Weeks 1 and 6
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| Locations: |
Tempe, Arizona, United States|Pine Bluff, Arkansas, United States|Azusa, California, United States|Los Angeles, California, United States|Northridge, California, United States|Ontario, California, United States|Paramount, California, United States|Yuba City, California, United States|Miami, Florida, United States|Pembroke Pines, Florida, United States|Honolulu, Hawaii, United States|Louisville, Kentucky, United States|Detroit, Michigan, United States|Kansas City, Missouri, United States|Paterson, New Jersey, United States|New York, New York, United States|Rosedale, New York, United States|Williamsville, New York, United States|Toledo, Ohio, United States|Orangeburg, South Carolina, United States|Arlington, Texas, United States|Fort Worth, Texas, United States|Houston, Texas, United States|San Antonio, Texas, United States|Fairfax, Virginia, United States
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