Adults 18 to 75, any sex, with Chronic Kidney Disease or Anemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number (%) of Participants With an Hb Response by Week 17Primary· Up to Week 17
An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
19
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
24
Cohort C: Roxadustat at 50 mg TIW
21
Cohort D: Roxadustat at 100 mg TIW
23
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
23
Cohort F: Roxadustat at 70 mg BIW Then QW
21
Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25Secondary· Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.
Week 5
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
15
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
14
Cohort C: Roxadustat at 50 mg TIW
3
Cohort D: Roxadustat at 100 mg TIW
13
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
9
Cohort F: Roxadustat at 70 mg BIW Then QW
9
Week 9
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
18
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
21
Cohort C: Roxadustat at 50 mg TIW
12
Cohort D: Roxadustat at 100 mg TIW
20
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
18
Cohort F: Roxadustat at 70 mg BIW Then QW
13
Week 13
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
18
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
23
Cohort C: Roxadustat at 50 mg TIW
15
Cohort D: Roxadustat at 100 mg TIW
21
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
20
Cohort F: Roxadustat at 70 mg BIW Then QW
16
Week 17
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
19
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
24
Cohort C: Roxadustat at 50 mg TIW
17
Cohort D: Roxadustat at 100 mg TIW
22
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
23
Cohort F: Roxadustat at 70 mg BIW Then QW
20
Week 21
Group
Value
95% CI
Cohort C: Roxadustat at 50 mg TIW
19
Cohort D: Roxadustat at 100 mg TIW
22
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
23
Cohort F: Roxadustat at 70 mg BIW Then QW
21
Week 25
Group
Value
95% CI
Cohort C: Roxadustat at 50 mg TIW
21
Cohort D: Roxadustat at 100 mg TIW
23
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
23
Cohort F: Roxadustat at 70 mg BIW Then QW
21
Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25Secondary· Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
Baseline is defined as the mean of the last 3 available values predose.
Baseline
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
9.56
± 0.88
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
9.67
± 0.62
Cohort C: Roxadustat at 50 mg TIW
9.80
± 0.50
Cohort D: Roxadustat at 100 mg TIW
9.68
± 0.77
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
9.89
± 0.60
Cohort F: Roxadustat at 70 mg BIW Then QW
9.72
± 0.60
Change at Week 5
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
1.71
± 1.02
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
1.11
± 0.96
Cohort C: Roxadustat at 50 mg TIW
0.57
± 0.65
Cohort D: Roxadustat at 100 mg TIW
1.65
± 0.95
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
0.74
± 0.75
Cohort F: Roxadustat at 70 mg BIW Then QW
0.63
± 0.85
Change at Week 9
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
2.58
± 0.97
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
1.77
± 1.18
Cohort C: Roxadustat at 50 mg TIW
0.99
± 0.87
Cohort D: Roxadustat at 100 mg TIW
2.21
± 1.02
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
1.67
± 0.98
Cohort F: Roxadustat at 70 mg BIW Then QW
0.89
± 1.23
Change at Week 13
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
2.46
± 0.93
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
2.06
± 1.07
Cohort C: Roxadustat at 50 mg TIW
1.26
± 1.09
Cohort D: Roxadustat at 100 mg TIW
2.17
± 1.19
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
1.43
± 0.90
Cohort F: Roxadustat at 70 mg BIW Then QW
1.19
± 1.10
Change at Week 17
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
2.63
± 0.83
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
2.28
± 0.87
Cohort C: Roxadustat at 50 mg TIW
1.43
± 1.15
Cohort D: Roxadustat at 100 mg TIW
2.26
± 1.31
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
1.50
± 0.73
Cohort F: Roxadustat at 70 mg BIW Then QW
1.46
± 1.23
Change at Week 21
Group
Value
95% CI
Cohort C: Roxadustat at 50 mg TIW
1.30
± 0.97
Cohort D: Roxadustat at 100 mg TIW
1.94
± 0.81
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
1.19
± 1.08
Cohort F: Roxadustat at 70 mg BIW Then QW
1.79
± 0.77
Change at Week 25
Group
Value
95% CI
Cohort C: Roxadustat at 50 mg TIW
1.33
± 1.00
Cohort D: Roxadustat at 100 mg TIW
1.73
± 1.14
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
1.28
± 1.08
Cohort F: Roxadustat at 70 mg BIW Then QW
1.51
± 1.06
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 25-28Secondary· 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)
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, HB Value of 11-12 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
4
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
11
Cohort C: Roxadustat at 50 mg TIW
7
Cohort D: Roxadustat at 100 mg TIW
8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
10
Cohort F: Roxadustat at 70 mg BIW Then QW
7
Weeks 5-8, HB Value of 11-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
13
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
14
Cohort C: Roxadustat at 50 mg TIW
7
Cohort D: Roxadustat at 100 mg TIW
12
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
13
Cohort F: Roxadustat at 70 mg BIW Then QW
8
Weeks 5-8, HB Value of 10.5-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
16
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
18
Cohort C: Roxadustat at 50 mg TIW
14
Cohort D: Roxadustat at 100 mg TIW
16
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
17
Cohort F: Roxadustat at 70 mg BIW Then QW
13
Weeks 9-12, HB Value of 11-12 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
5
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
12
Cohort C: Roxadustat at 50 mg TIW
7
Cohort D: Roxadustat at 100 mg TIW
8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
9
Cohort F: Roxadustat at 70 mg BIW Then QW
6
Weeks 9-12, HB Value of 11-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
13
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
18
Cohort C: Roxadustat at 50 mg TIW
9
Cohort D: Roxadustat at 100 mg TIW
16
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
12
Cohort F: Roxadustat at 70 mg BIW Then QW
10
Weeks 9-12, HB Value of 10.5-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
14
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
21
Cohort C: Roxadustat at 50 mg TIW
16
Cohort D: Roxadustat at 100 mg TIW
17
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
16
Cohort F: Roxadustat at 70 mg BIW Then QW
15
Weeks 9-16, HB Value of 11-12 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
6
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
11
Cohort C: Roxadustat at 50 mg TIW
8
Cohort D: Roxadustat at 100 mg TIW
8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
11
Cohort F: Roxadustat at 70 mg BIW Then QW
7
Weeks 9-16, HB Value of 11-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
12
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
19
Cohort C: Roxadustat at 50 mg TIW
11
Cohort D: Roxadustat at 100 mg TIW
16
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
14
Cohort F: Roxadustat at 70 mg BIW Then QW
11
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 25-28Secondary· 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)
Weeks 5-8, Hb Value of 11-12 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
4
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
11
Cohort C: Roxadustat at 50 mg TIW
5
Cohort D: Roxadustat at 100 mg TIW
9
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
8
Cohort F: Roxadustat at 70 mg BIW Then QW
4
Weeks 5-8, Hb Value of 11-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
13
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
14
Cohort C: Roxadustat at 50 mg TIW
8
Cohort D: Roxadustat at 100 mg TIW
12
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
12
Cohort F: Roxadustat at 70 mg BIW Then QW
6
Weeks 5-8, Hb Value of 10.5-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
15
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
17
Cohort C: Roxadustat at 50 mg TIW
14
Cohort D: Roxadustat at 100 mg TIW
16
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
16
Cohort F: Roxadustat at 70 mg BIW Then QW
13
Weeks 9-12, Hb Value of 11-12 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
5
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
12
Cohort C: Roxadustat at 50 mg TIW
7
Cohort D: Roxadustat at 100 mg TIW
8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
10
Cohort F: Roxadustat at 70 mg BIW Then QW
8
Weeks 9-12, Hb Value of 11-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
12
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
17
Cohort C: Roxadustat at 50 mg TIW
10
Cohort D: Roxadustat at 100 mg TIW
16
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
12
Cohort F: Roxadustat at 70 mg BIW Then QW
11
Weeks 9-12, Hb Value of 10.5-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
14
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
21
Cohort C: Roxadustat at 50 mg TIW
16
Cohort D: Roxadustat at 100 mg TIW
18
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
17
Cohort F: Roxadustat at 70 mg BIW Then QW
15
Weeks 9-16, Hb Value of 11-12 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
8
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
16
Cohort C: Roxadustat at 50 mg TIW
10
Cohort D: Roxadustat at 100 mg TIW
10
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
15
Cohort F: Roxadustat at 70 mg BIW Then QW
11
Weeks 9-16, Hb Value of 11-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
14
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
22
Cohort C: Roxadustat at 50 mg TIW
13
Cohort D: Roxadustat at 100 mg TIW
20
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
18
Cohort F: Roxadustat at 70 mg BIW Then QW
15
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 25Secondary· Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks.
Hb Value of 11-12 g/dL by Week 5
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
9
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
11
Cohort C: Roxadustat at 50 mg TIW
5
Cohort D: Roxadustat at 100 mg TIW
8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
11
Cohort F: Roxadustat at 70 mg BIW Then QW
10
Hb Value of 11-12 g/dL by Week 9
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
11
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
16
Cohort C: Roxadustat at 50 mg TIW
11
Cohort D: Roxadustat at 100 mg TIW
11
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
15
Cohort F: Roxadustat at 70 mg BIW Then QW
14
Hb Value of 11-12 g/dL by Week 13
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
11
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
19
Cohort C: Roxadustat at 50 mg TIW
14
Cohort D: Roxadustat at 100 mg TIW
13
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
17
Cohort F: Roxadustat at 70 mg BIW Then QW
17
Hb Value of 11-12 g/dL by Week 17
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
12
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
20
Cohort C: Roxadustat at 50 mg TIW
16
Cohort D: Roxadustat at 100 mg TIW
14
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
17
Cohort F: Roxadustat at 70 mg BIW Then QW
20
Hb Value of 11-12 g/dL by Week 21
Group
Value
95% CI
Cohort C: Roxadustat at 50 mg TIW
17
Cohort D: Roxadustat at 100 mg TIW
15
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
19
Cohort F: Roxadustat at 70 mg BIW Then QW
22
Hb Value of 11-12 g/dL by Week 25
Group
Value
95% CI
Cohort C: Roxadustat at 50 mg TIW
21
Cohort D: Roxadustat at 100 mg TIW
18
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
20
Cohort F: Roxadustat at 70 mg BIW Then QW
22
Hb Value of 11-13 g/dL by Week 5
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
16
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
14
Cohort C: Roxadustat at 50 mg TIW
6
Cohort D: Roxadustat at 100 mg TIW
14
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
13
Cohort F: Roxadustat at 70 mg BIW Then QW
10
Hb Value of 11-13 g/dL by Week 9
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
18
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
21
Cohort C: Roxadustat at 50 mg TIW
14
Cohort D: Roxadustat at 100 mg TIW
19
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
18
Cohort F: Roxadustat at 70 mg BIW Then QW
14
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 25-28Secondary· 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)
Weeks 5-8, Hb Value of <11 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
6
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
9
Cohort C: Roxadustat at 50 mg TIW
10
Cohort D: Roxadustat at 100 mg TIW
5
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
6
Cohort F: Roxadustat at 70 mg BIW Then QW
13
Weeks 5-8, Hb Value of 12-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
10
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
6
Cohort C: Roxadustat at 50 mg TIW
4
Cohort D: Roxadustat at 100 mg TIW
6
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
4
Cohort F: Roxadustat at 70 mg BIW Then QW
3
Weeks 5-8, Hb Value of 13-14 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
2
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
1
Cohort C: Roxadustat at 50 mg TIW
0
Cohort D: Roxadustat at 100 mg TIW
3
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
1
Cohort F: Roxadustat at 70 mg BIW Then QW
0
Weeks 5-8, Hb Value of >14 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
1
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
0
Cohort C: Roxadustat at 50 mg TIW
0
Cohort D: Roxadustat at 100 mg TIW
1
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
0
Cohort F: Roxadustat at 70 mg BIW Then QW
0
Weeks 9-12, Hb Value of <11 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
4
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
2
Cohort C: Roxadustat at 50 mg TIW
9
Cohort D: Roxadustat at 100 mg TIW
4
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
7
Cohort F: Roxadustat at 70 mg BIW Then QW
11
Weeks 9-12, Hb Value of 12-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
5
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
9
Cohort C: Roxadustat at 50 mg TIW
4
Cohort D: Roxadustat at 100 mg TIW
8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
6
Cohort F: Roxadustat at 70 mg BIW Then QW
6
Weeks 9-12, Hb Value of 13-14 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
7
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
1
Cohort C: Roxadustat at 50 mg TIW
1
Cohort D: Roxadustat at 100 mg TIW
3
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
3
Cohort F: Roxadustat at 70 mg BIW Then QW
0
Weeks 9-12, Hb Value of >14 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
2
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
1
Cohort C: Roxadustat at 50 mg TIW
0
Cohort D: Roxadustat at 100 mg TIW
2
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
0
Cohort F: Roxadustat at 70 mg BIW Then QW
0
Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dLSecondary· Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)
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.
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
28.0
28.0 – 56.0
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
28.0
28.0 – 56.0
Cohort C: Roxadustat at 50 mg TIW
48.9
28.0 – 56.0
Cohort D: Roxadustat at 100 mg TIW
28.0
28.0 – 56.0
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
35.0
28.0 – 56.0
Cohort F: Roxadustat at 70 mg BIW Then QW
56.0
28.0 – 56.0
Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From BaselineSecondary· Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F)
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.
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
21.0
21.0 – 42.0
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
21.6
21.0 – 42.0
Cohort C: Roxadustat at 50 mg TIW
42.0
21.0 – 42.0
Cohort D: Roxadustat at 100 mg TIW
21.0
21.0 – 42.0
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
35.0
21.0 – 42.0
Cohort F: Roxadustat at 70 mg BIW Then QW
42.0
21.0 – 42.0
Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From BaselineSecondary· Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
2.30
0.6 – 6.4
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
2.50
1.4 – 4.4
Cohort C: Roxadustat at 50 mg TIW
2.32
0.7 – 6.6
Cohort D: Roxadustat at 100 mg TIW
2.36
0.8 – 6.5
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
1.96
0.5 – 4.9
Cohort F: Roxadustat at 70 mg BIW Then QW
1.61
0.8 – 4.6
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by WeekSecondary· 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)
Hb at Response Timepoint
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
11.49
± 0.414
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
11.40
± 0.289
Cohort C: Roxadustat at 50 mg TIW
11.32
± 0.360
Cohort D: Roxadustat at 100 mg TIW
11.47
± 0.430
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
11.62
± 0.543
Cohort F: Roxadustat at 70 mg BIW Then QW
11.43
± 0.348
Change after 1 week
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
0.30
± 0.579
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
0.03
± 0.562
Cohort C: Roxadustat at 50 mg TIW
-0.18
± 0.854
Cohort D: Roxadustat at 100 mg TIW
0.18
± 0.570
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
-0.26
± 0.709
Cohort F: Roxadustat at 70 mg BIW Then QW
-0.23
± 0.394
Change after 2 weeks
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
0.46
± 0.685
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
0.05
± 0.634
Cohort C: Roxadustat at 50 mg TIW
-0.22
± 0.868
Cohort D: Roxadustat at 100 mg TIW
0.41
± 0.678
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
-0.34
± 0.720
Cohort F: Roxadustat at 70 mg BIW Then QW
-0.21
± 0.707
Change after 3 weeks
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
0.67
± 0.635
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
0.19
± 0.720
Cohort C: Roxadustat at 50 mg TIW
-0.02
± 0.842
Cohort D: Roxadustat at 100 mg TIW
0.44
± 0.873
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
-0.31
± 0.934
Cohort F: Roxadustat at 70 mg BIW Then QW
-0.25
± 0.682
Change after 4 weeks
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
0.81
± 0.642
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
0.17
± 0.968
Cohort C: Roxadustat at 50 mg TIW
0.06
± 0.767
Cohort D: Roxadustat at 100 mg TIW
0.61
± 0.859
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
-0.18
± 1.080
Cohort F: Roxadustat at 70 mg BIW Then QW
-0.24
± 0.794
Change after 5 weeks
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
0.99
± 0.705
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
0.20
± 1.004
Cohort C: Roxadustat at 50 mg TIW
-0.07
± 0.701
Cohort D: Roxadustat at 100 mg TIW
0.65
± 0.883
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
-0.05
± 1.295
Cohort F: Roxadustat at 70 mg BIW Then QW
0.13
± 0.752
Change after 6 weeks
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
1.01
± 0.999
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
0.23
± 0.931
Cohort C: Roxadustat at 50 mg TIW
0.02
± 0.821
Cohort D: Roxadustat at 100 mg TIW
0.67
± 0.799
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
0.10
± 1.274
Cohort F: Roxadustat at 70 mg BIW Then QW
-0.01
± 0.937
Change after 7 weeks
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
0.97
± 0.874
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
0.21
± 0.860
Cohort C: Roxadustat at 50 mg TIW
0.40
± 0.876
Cohort D: Roxadustat at 100 mg TIW
0.87
± 0.882
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
-0.21
± 1.255
Cohort F: Roxadustat at 70 mg BIW Then QW
0.03
± 0.830
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 CategoriesSecondary· 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])
After Response through EoT, Hb Category <11 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
11.50
± 25.937
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
18.75
± 27.254
Cohort C: Roxadustat at 50 mg TIW
35.48
± 32.727
Cohort D: Roxadustat at 100 mg TIW
14.03
± 18.311
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
38.32
± 30.175
Cohort F: Roxadustat at 70 mg BIW Then QW
32.56
± 33.384
After Response through EoT, Hb Category 11-12 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
31.46
± 30.410
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
48.86
± 26.771
Cohort C: Roxadustat at 50 mg TIW
46.67
± 29.540
Cohort D: Roxadustat at 100 mg TIW
41.54
± 26.619
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
44.17
± 22.858
Cohort F: Roxadustat at 70 mg BIW Then QW
47.00
± 27.692
After Response through EoT, Hb Category 11-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
66.73
± 27.453
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
76.05
± 26.577
Cohort C: Roxadustat at 50 mg TIW
62.10
± 31.528
Cohort D: Roxadustat at 100 mg TIW
74.96
± 24.078
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
56.92
± 27.338
Cohort F: Roxadustat at 70 mg BIW Then QW
64.39
± 32.083
After Response through EoT, Hb Category 10.5-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
76.80
± 23.899
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
87.20
± 20.118
Cohort C: Roxadustat at 50 mg TIW
82.69
± 25.854
Cohort D: Roxadustat at 100 mg TIW
83.50
± 21.354
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
79.01
± 23.045
Cohort F: Roxadustat at 70 mg BIW Then QW
83.97
± 26.219
In Follow Up, Hb Category <11 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
16.67
± 34.300
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
35.71
± 42.258
Cohort C: Roxadustat at 50 mg TIW
54.76
± 41.547
Cohort D: Roxadustat at 100 mg TIW
47.83
± 43.896
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
57.50
± 43.755
Cohort F: Roxadustat at 70 mg BIW Then QW
50.00
± 44.096
In Follow Up, Hb Category 11-12 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
30.56
± 38.877
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
40.48
± 40.679
Cohort C: Roxadustat at 50 mg TIW
40.48
± 40.679
Cohort D: Roxadustat at 100 mg TIW
41.30
± 38.883
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
30.00
± 37.697
Cohort F: Roxadustat at 70 mg BIW Then QW
47.37
± 42.406
In Follow Up, Hb Category 11-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
69.44
± 42.492
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
59.52
± 40.679
Cohort C: Roxadustat at 50 mg TIW
45.24
± 41.547
Cohort D: Roxadustat at 100 mg TIW
52.17
± 43.896
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
42.50
± 43.755
Cohort F: Roxadustat at 70 mg BIW Then QW
50.00
± 44.096
In Follow Up, Hb Category 10.5-13 g/dL
Group
Value
95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
75.00
± 39.295
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
83.33
± 32.914
Cohort C: Roxadustat at 50 mg TIW
66.67
± 36.515
Cohort D: Roxadustat at 100 mg TIW
71.74
± 39.388
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
65.00
± 43.225
Cohort F: Roxadustat at 70 mg BIW Then QW
73.68
± 34.835
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to Week 28 (end of study).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
Serious: 3/24 (13%)
Deaths: —
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
Serious: 4/24 (17%)
Deaths: —
Cohort C: Roxadustat at 50 mg TIW
Serious: 4/24 (17%)
Deaths: —
Cohort D: Roxadustat at 100 mg TIW
Serious: 4/24 (17%)
Deaths: —
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07268807 — Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease
· not yet recruiting
NCT07162090 — Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients
· Phase 4
· not yet recruiting
NCT05810311 — The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy
· Phase 2
· not yet recruiting
NCT06903559 — Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients
· Phase 1, PHASE2
· recruiting
NCT06917950 — Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients
· Phase 1, PHASE2
· recruiting
Other recruiting trials for Chronic Kidney Disease
Currently open trials in the same condition.
NCT07469540 — Effects of an Aerobic Exercise Program on Cardiovascular Risk in Patients With Chronic Kidney Disease or Rheumatoid Arth
· NA
· recruiting
NCT07169422 — Improving Kidney Care in Type 2 Diabetes: A Study of Pharmacist Prescribing Versus Usual Care
· NA
· recruiting
NCT07481526 — A Prospecitve Multicenter, Observational Registry Study
· recruiting
NCT07450820 — OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD
· recruiting
NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease
· Phase 3
· recruiting
Other Kyntra Bio trials
Trials by the same sponsor.
NCT06842498 — A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
· Phase 2
· recruiting
NCT04621331 — Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
· Phase 3
· withdrawn
NCT05301517 — A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemothe
· Phase 3
· completed
NCT04632940 — Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD
· Phase 3
· terminated
NCT04419558 — Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
· Phase 3
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kyntra Bio
Last refreshed: 10 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01244763.