The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
Oral capsule
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.
Time frame: Up to Week 17
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Pine Bluff, Arkansas, United States
Unnamed facility
Azusa, California, United States
Unnamed facility
Chula Vista, California, United States
Unnamed facility
Downey, California, United States
Unnamed facility
Northridge, California, United States
Unnamed facility
Paramount, California, United States
Unnamed facility
Riverside, California, United States
Unnamed facility
Whittier, California, United States
Unnamed facility
Yuba City, California, United States
...and 28 more locations
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline up to Week 28 (end of study)
Number (%) of Participants Requiring Therapeutic Phlebotomy
Time frame: Baseline up to Week 28 (end of study)
Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment)