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NCT01244763

Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia

Completed Phase 2 Results posted Last updated 10 February 2022
What this trial tests

Phase 2 trial testing Roxadustat in Chronic Kidney Disease in 145 participants. Completed in 13 June 2012.

Timeline
29 October 2010
Primary endpoint
13 June 2012
13 June 2012

Quick facts

Lead sponsorKyntra Bio
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment145
Start date29 October 2010
Primary completion13 June 2012
Estimated completion13 June 2012
Sites38 locations across Puerto Rico, United States

Drugs / interventions tested

Conditions studied

Sponsor

Kyntra Bio — full company profile →

Who can join

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 17 Primary · 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.

GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW19
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW24
Cohort C: Roxadustat at 50 mg TIW21
Cohort D: Roxadustat at 100 mg TIW23
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW23
Cohort F: Roxadustat at 70 mg BIW Then QW21
Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 Secondary · 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW15
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW14
Cohort C: Roxadustat at 50 mg TIW3
Cohort D: Roxadustat at 100 mg TIW13
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW9
Cohort F: Roxadustat at 70 mg BIW Then QW9
Week 9
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW18
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW21
Cohort C: Roxadustat at 50 mg TIW12
Cohort D: Roxadustat at 100 mg TIW20
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW18
Cohort F: Roxadustat at 70 mg BIW Then QW13
Week 13
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW18
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW23
Cohort C: Roxadustat at 50 mg TIW15
Cohort D: Roxadustat at 100 mg TIW21
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW20
Cohort F: Roxadustat at 70 mg BIW Then QW16
Week 17
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW19
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW24
Cohort C: Roxadustat at 50 mg TIW17
Cohort D: Roxadustat at 100 mg TIW22
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW23
Cohort F: Roxadustat at 70 mg BIW Then QW20
Week 21
GroupValue95% CI
Cohort C: Roxadustat at 50 mg TIW19
Cohort D: Roxadustat at 100 mg TIW22
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW23
Cohort F: Roxadustat at 70 mg BIW Then QW21
Week 25
GroupValue95% CI
Cohort C: Roxadustat at 50 mg TIW21
Cohort D: Roxadustat at 100 mg TIW23
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW23
Cohort F: Roxadustat at 70 mg BIW Then QW21
Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 Secondary · 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW9.56± 0.88
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW9.67± 0.62
Cohort C: Roxadustat at 50 mg TIW9.80± 0.50
Cohort D: Roxadustat at 100 mg TIW9.68± 0.77
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW9.89± 0.60
Cohort F: Roxadustat at 70 mg BIW Then QW9.72± 0.60
Change at Week 5
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW1.71± 1.02
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW1.11± 0.96
Cohort C: Roxadustat at 50 mg TIW0.57± 0.65
Cohort D: Roxadustat at 100 mg TIW1.65± 0.95
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW0.74± 0.75
Cohort F: Roxadustat at 70 mg BIW Then QW0.63± 0.85
Change at Week 9
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW2.58± 0.97
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW1.77± 1.18
Cohort C: Roxadustat at 50 mg TIW0.99± 0.87
Cohort D: Roxadustat at 100 mg TIW2.21± 1.02
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW1.67± 0.98
Cohort F: Roxadustat at 70 mg BIW Then QW0.89± 1.23
Change at Week 13
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW2.46± 0.93
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW2.06± 1.07
Cohort C: Roxadustat at 50 mg TIW1.26± 1.09
Cohort D: Roxadustat at 100 mg TIW2.17± 1.19
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW1.43± 0.90
Cohort F: Roxadustat at 70 mg BIW Then QW1.19± 1.10
Change at Week 17
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW2.63± 0.83
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW2.28± 0.87
Cohort C: Roxadustat at 50 mg TIW1.43± 1.15
Cohort D: Roxadustat at 100 mg TIW2.26± 1.31
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW1.50± 0.73
Cohort F: Roxadustat at 70 mg BIW Then QW1.46± 1.23
Change at Week 21
GroupValue95% CI
Cohort C: Roxadustat at 50 mg TIW1.30± 0.97
Cohort D: Roxadustat at 100 mg TIW1.94± 0.81
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW1.19± 1.08
Cohort F: Roxadustat at 70 mg BIW Then QW1.79± 0.77
Change at Week 25
GroupValue95% CI
Cohort C: Roxadustat at 50 mg TIW1.33± 1.00
Cohort D: Roxadustat at 100 mg TIW1.73± 1.14
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW1.28± 1.08
Cohort F: Roxadustat at 70 mg BIW Then QW1.51± 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 25-28 Secondary · 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW4
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW11
Cohort C: Roxadustat at 50 mg TIW7
Cohort D: Roxadustat at 100 mg TIW8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW10
Cohort F: Roxadustat at 70 mg BIW Then QW7
Weeks 5-8, HB Value of 11-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW13
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW14
Cohort C: Roxadustat at 50 mg TIW7
Cohort D: Roxadustat at 100 mg TIW12
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW13
Cohort F: Roxadustat at 70 mg BIW Then QW8
Weeks 5-8, HB Value of 10.5-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW16
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW18
Cohort C: Roxadustat at 50 mg TIW14
Cohort D: Roxadustat at 100 mg TIW16
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW17
Cohort F: Roxadustat at 70 mg BIW Then QW13
Weeks 9-12, HB Value of 11-12 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW5
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW12
Cohort C: Roxadustat at 50 mg TIW7
Cohort D: Roxadustat at 100 mg TIW8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW9
Cohort F: Roxadustat at 70 mg BIW Then QW6
Weeks 9-12, HB Value of 11-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW13
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW18
Cohort C: Roxadustat at 50 mg TIW9
Cohort D: Roxadustat at 100 mg TIW16
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW12
Cohort F: Roxadustat at 70 mg BIW Then QW10
Weeks 9-12, HB Value of 10.5-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW14
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW21
Cohort C: Roxadustat at 50 mg TIW16
Cohort D: Roxadustat at 100 mg TIW17
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW16
Cohort F: Roxadustat at 70 mg BIW Then QW15
Weeks 9-16, HB Value of 11-12 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW6
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW11
Cohort C: Roxadustat at 50 mg TIW8
Cohort D: Roxadustat at 100 mg TIW8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW11
Cohort F: Roxadustat at 70 mg BIW Then QW7
Weeks 9-16, HB Value of 11-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW12
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW19
Cohort C: Roxadustat at 50 mg TIW11
Cohort D: Roxadustat at 100 mg TIW16
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW14
Cohort F: Roxadustat at 70 mg BIW Then QW11
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 Secondary · 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW4
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW11
Cohort C: Roxadustat at 50 mg TIW5
Cohort D: Roxadustat at 100 mg TIW9
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW8
Cohort F: Roxadustat at 70 mg BIW Then QW4
Weeks 5-8, Hb Value of 11-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW13
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW14
Cohort C: Roxadustat at 50 mg TIW8
Cohort D: Roxadustat at 100 mg TIW12
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW12
Cohort F: Roxadustat at 70 mg BIW Then QW6
Weeks 5-8, Hb Value of 10.5-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW15
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW17
Cohort C: Roxadustat at 50 mg TIW14
Cohort D: Roxadustat at 100 mg TIW16
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW16
Cohort F: Roxadustat at 70 mg BIW Then QW13
Weeks 9-12, Hb Value of 11-12 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW5
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW12
Cohort C: Roxadustat at 50 mg TIW7
Cohort D: Roxadustat at 100 mg TIW8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW10
Cohort F: Roxadustat at 70 mg BIW Then QW8
Weeks 9-12, Hb Value of 11-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW12
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW17
Cohort C: Roxadustat at 50 mg TIW10
Cohort D: Roxadustat at 100 mg TIW16
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW12
Cohort F: Roxadustat at 70 mg BIW Then QW11
Weeks 9-12, Hb Value of 10.5-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW14
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW21
Cohort C: Roxadustat at 50 mg TIW16
Cohort D: Roxadustat at 100 mg TIW18
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW17
Cohort F: Roxadustat at 70 mg BIW Then QW15
Weeks 9-16, Hb Value of 11-12 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW8
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW16
Cohort C: Roxadustat at 50 mg TIW10
Cohort D: Roxadustat at 100 mg TIW10
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW15
Cohort F: Roxadustat at 70 mg BIW Then QW11
Weeks 9-16, Hb Value of 11-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW14
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW22
Cohort C: Roxadustat at 50 mg TIW13
Cohort D: Roxadustat at 100 mg TIW20
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW18
Cohort F: Roxadustat at 70 mg BIW Then QW15
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 Secondary · 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW9
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW11
Cohort C: Roxadustat at 50 mg TIW5
Cohort D: Roxadustat at 100 mg TIW8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW11
Cohort F: Roxadustat at 70 mg BIW Then QW10
Hb Value of 11-12 g/dL by Week 9
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW11
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW16
Cohort C: Roxadustat at 50 mg TIW11
Cohort D: Roxadustat at 100 mg TIW11
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW15
Cohort F: Roxadustat at 70 mg BIW Then QW14
Hb Value of 11-12 g/dL by Week 13
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW11
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW19
Cohort C: Roxadustat at 50 mg TIW14
Cohort D: Roxadustat at 100 mg TIW13
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW17
Cohort F: Roxadustat at 70 mg BIW Then QW17
Hb Value of 11-12 g/dL by Week 17
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW12
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW20
Cohort C: Roxadustat at 50 mg TIW16
Cohort D: Roxadustat at 100 mg TIW14
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW17
Cohort F: Roxadustat at 70 mg BIW Then QW20
Hb Value of 11-12 g/dL by Week 21
GroupValue95% CI
Cohort C: Roxadustat at 50 mg TIW17
Cohort D: Roxadustat at 100 mg TIW15
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW19
Cohort F: Roxadustat at 70 mg BIW Then QW22
Hb Value of 11-12 g/dL by Week 25
GroupValue95% CI
Cohort C: Roxadustat at 50 mg TIW21
Cohort D: Roxadustat at 100 mg TIW18
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW20
Cohort F: Roxadustat at 70 mg BIW Then QW22
Hb Value of 11-13 g/dL by Week 5
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW16
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW14
Cohort C: Roxadustat at 50 mg TIW6
Cohort D: Roxadustat at 100 mg TIW14
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW13
Cohort F: Roxadustat at 70 mg BIW Then QW10
Hb Value of 11-13 g/dL by Week 9
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW18
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW21
Cohort C: Roxadustat at 50 mg TIW14
Cohort D: Roxadustat at 100 mg TIW19
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW18
Cohort F: Roxadustat at 70 mg BIW Then QW14
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 Secondary · 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW6
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW9
Cohort C: Roxadustat at 50 mg TIW10
Cohort D: Roxadustat at 100 mg TIW5
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW6
Cohort F: Roxadustat at 70 mg BIW Then QW13
Weeks 5-8, Hb Value of 12-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW10
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW6
Cohort C: Roxadustat at 50 mg TIW4
Cohort D: Roxadustat at 100 mg TIW6
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW4
Cohort F: Roxadustat at 70 mg BIW Then QW3
Weeks 5-8, Hb Value of 13-14 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW2
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW1
Cohort C: Roxadustat at 50 mg TIW0
Cohort D: Roxadustat at 100 mg TIW3
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW1
Cohort F: Roxadustat at 70 mg BIW Then QW0
Weeks 5-8, Hb Value of >14 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW1
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW0
Cohort C: Roxadustat at 50 mg TIW0
Cohort D: Roxadustat at 100 mg TIW1
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW0
Cohort F: Roxadustat at 70 mg BIW Then QW0
Weeks 9-12, Hb Value of <11 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW4
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW2
Cohort C: Roxadustat at 50 mg TIW9
Cohort D: Roxadustat at 100 mg TIW4
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW7
Cohort F: Roxadustat at 70 mg BIW Then QW11
Weeks 9-12, Hb Value of 12-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW5
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW9
Cohort C: Roxadustat at 50 mg TIW4
Cohort D: Roxadustat at 100 mg TIW8
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW6
Cohort F: Roxadustat at 70 mg BIW Then QW6
Weeks 9-12, Hb Value of 13-14 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW7
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW1
Cohort C: Roxadustat at 50 mg TIW1
Cohort D: Roxadustat at 100 mg TIW3
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW3
Cohort F: Roxadustat at 70 mg BIW Then QW0
Weeks 9-12, Hb Value of >14 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW2
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW1
Cohort C: Roxadustat at 50 mg TIW0
Cohort D: Roxadustat at 100 mg TIW2
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW0
Cohort F: Roxadustat at 70 mg BIW Then QW0
Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL Secondary · 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.

GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW28.028.0 – 56.0
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW28.028.0 – 56.0
Cohort C: Roxadustat at 50 mg TIW48.928.0 – 56.0
Cohort D: Roxadustat at 100 mg TIW28.028.0 – 56.0
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW35.028.0 – 56.0
Cohort F: Roxadustat at 70 mg BIW Then QW56.028.0 – 56.0
Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline Secondary · 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.

GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW21.021.0 – 42.0
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW21.621.0 – 42.0
Cohort C: Roxadustat at 50 mg TIW42.021.0 – 42.0
Cohort D: Roxadustat at 100 mg TIW21.021.0 – 42.0
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW35.021.0 – 42.0
Cohort F: Roxadustat at 70 mg BIW Then QW42.021.0 – 42.0
Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline Secondary · Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW2.300.6 – 6.4
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW2.501.4 – 4.4
Cohort C: Roxadustat at 50 mg TIW2.320.7 – 6.6
Cohort D: Roxadustat at 100 mg TIW2.360.8 – 6.5
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW1.960.5 – 4.9
Cohort F: Roxadustat at 70 mg BIW Then QW1.610.8 – 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 Week Secondary · 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW11.49± 0.414
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW11.40± 0.289
Cohort C: Roxadustat at 50 mg TIW11.32± 0.360
Cohort D: Roxadustat at 100 mg TIW11.47± 0.430
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW11.62± 0.543
Cohort F: Roxadustat at 70 mg BIW Then QW11.43± 0.348
Change after 1 week
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW0.30± 0.579
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW0.03± 0.562
Cohort C: Roxadustat at 50 mg TIW-0.18± 0.854
Cohort D: Roxadustat at 100 mg TIW0.18± 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW0.46± 0.685
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW0.05± 0.634
Cohort C: Roxadustat at 50 mg TIW-0.22± 0.868
Cohort D: Roxadustat at 100 mg TIW0.41± 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW0.67± 0.635
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW0.19± 0.720
Cohort C: Roxadustat at 50 mg TIW-0.02± 0.842
Cohort D: Roxadustat at 100 mg TIW0.44± 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW0.81± 0.642
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW0.17± 0.968
Cohort C: Roxadustat at 50 mg TIW0.06± 0.767
Cohort D: Roxadustat at 100 mg TIW0.61± 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW0.99± 0.705
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW0.20± 1.004
Cohort C: Roxadustat at 50 mg TIW-0.07± 0.701
Cohort D: Roxadustat at 100 mg TIW0.65± 0.883
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW-0.05± 1.295
Cohort F: Roxadustat at 70 mg BIW Then QW0.13± 0.752
Change after 6 weeks
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW1.01± 0.999
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW0.23± 0.931
Cohort C: Roxadustat at 50 mg TIW0.02± 0.821
Cohort D: Roxadustat at 100 mg TIW0.67± 0.799
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW0.10± 1.274
Cohort F: Roxadustat at 70 mg BIW Then QW-0.01± 0.937
Change after 7 weeks
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW0.97± 0.874
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW0.21± 0.860
Cohort C: Roxadustat at 50 mg TIW0.40± 0.876
Cohort D: Roxadustat at 100 mg TIW0.87± 0.882
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW-0.21± 1.255
Cohort F: Roxadustat at 70 mg BIW Then QW0.03± 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 Categories Secondary · 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
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW11.50± 25.937
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW18.75± 27.254
Cohort C: Roxadustat at 50 mg TIW35.48± 32.727
Cohort D: Roxadustat at 100 mg TIW14.03± 18.311
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW38.32± 30.175
Cohort F: Roxadustat at 70 mg BIW Then QW32.56± 33.384
After Response through EoT, Hb Category 11-12 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW31.46± 30.410
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW48.86± 26.771
Cohort C: Roxadustat at 50 mg TIW46.67± 29.540
Cohort D: Roxadustat at 100 mg TIW41.54± 26.619
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW44.17± 22.858
Cohort F: Roxadustat at 70 mg BIW Then QW47.00± 27.692
After Response through EoT, Hb Category 11-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW66.73± 27.453
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW76.05± 26.577
Cohort C: Roxadustat at 50 mg TIW62.10± 31.528
Cohort D: Roxadustat at 100 mg TIW74.96± 24.078
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW56.92± 27.338
Cohort F: Roxadustat at 70 mg BIW Then QW64.39± 32.083
After Response through EoT, Hb Category 10.5-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW76.80± 23.899
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW87.20± 20.118
Cohort C: Roxadustat at 50 mg TIW82.69± 25.854
Cohort D: Roxadustat at 100 mg TIW83.50± 21.354
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW79.01± 23.045
Cohort F: Roxadustat at 70 mg BIW Then QW83.97± 26.219
In Follow Up, Hb Category <11 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW16.67± 34.300
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW35.71± 42.258
Cohort C: Roxadustat at 50 mg TIW54.76± 41.547
Cohort D: Roxadustat at 100 mg TIW47.83± 43.896
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW57.50± 43.755
Cohort F: Roxadustat at 70 mg BIW Then QW50.00± 44.096
In Follow Up, Hb Category 11-12 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW30.56± 38.877
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW40.48± 40.679
Cohort C: Roxadustat at 50 mg TIW40.48± 40.679
Cohort D: Roxadustat at 100 mg TIW41.30± 38.883
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW30.00± 37.697
Cohort F: Roxadustat at 70 mg BIW Then QW47.37± 42.406
In Follow Up, Hb Category 11-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW69.44± 42.492
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW59.52± 40.679
Cohort C: Roxadustat at 50 mg TIW45.24± 41.547
Cohort D: Roxadustat at 100 mg TIW52.17± 43.896
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW42.50± 43.755
Cohort F: Roxadustat at 70 mg BIW Then QW50.00± 44.096
In Follow Up, Hb Category 10.5-13 g/dL
GroupValue95% CI
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW75.00± 39.295
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW83.33± 32.914
Cohort C: Roxadustat at 50 mg TIW66.67± 36.515
Cohort D: Roxadustat at 100 mg TIW71.74± 39.388
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW65.00± 43.225
Cohort F: Roxadustat at 70 mg BIW Then QW73.68± 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
Serious: 10/24 (42%)
Deaths:
Cohort F: Roxadustat at 70 mg BIW Then QW
Serious: 10/25 (40%)
Deaths:

Serious adverse events (40 terms)

ReactionSystemCohort A: Roxadustat Tiere…Cohort B: Roxadustat Tiere…Cohort C: Roxadustat at 50…Cohort D: Roxadustat at 10…Cohort E: Roxadustat Tiere…Cohort F: Roxadustat at 70…
Cardiac Failure CongestiveCardiac disorders
CellulitisInfections and infestations
Cardio-Respiratory ArrestCardiac disorders
Acute Myocardial InfarctionCardiac disorders
Atrial FibrillationCardiac disorders
Myocardial InfarctionCardiac disorders
Renal Failure AcuteRenal and urinary disorders
Renal Failure ChronicRenal and urinary disorders
Renal ImpairmentRenal and urinary disorders
PancreatitisGastrointestinal disorders
Abdominal Pain LowerGastrointestinal disorders
Diabetic GastroparesisGastrointestinal disorders
HaematemesisGastrointestinal disorders
Pancreatitis AcuteGastrointestinal disorders
AbscessInfections and infestations
BronchopneumoniaInfections and infestations
PneumoniaInfections and infestations
HyponatraemiaMetabolism and nutrition disorders
Diabetic KetoacidosisMetabolism and nutrition disorders
Hyperglycaemic Hyperosmolar Nonketotic SyndromeMetabolism and nutrition disorders
Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders
Pulmonary OedemaRespiratory, thoracic and mediastinal disorders
Other adverse events (11 terms — click to expand)

ReactionSystemCohort A: Roxadustat Tiere…Cohort B: Roxadustat Tiere…Cohort C: Roxadustat at 50…Cohort D: Roxadustat at 10…Cohort E: Roxadustat Tiere…Cohort F: Roxadustat at 70…
NauseaGastrointestinal disorders
Oedema PeripheralGeneral disorders
Urinary Tract InfectionInfections and infestations
DiarrhoeaGastrointestinal disorders
HypertensionVascular disorders
NasopharyngitisInfections and infestations
SinusitisInfections and infestations
ConstipationGastrointestinal disorders
VomitingGastrointestinal disorders
DizzinessNervous system disorders
HeadacheNervous system disorders

Most-reported serious reactions: Cardiac Failure Congestive, Cellulitis, Cardio-Respiratory Arrest, Acute Myocardial Infarction, Atrial Fibrillation, Myocardial Infarction, Renal Failure Acute, Renal Failure Chronic.

Data from ClinicalTrials.gov NCT01244763 adverse events section.

Sponsor's own description

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):

  1. Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG-4592) for the Treatment of Anemia in Patients with CKD.
    Provenzano R, Besarab A, Sun CH, Diamond SA, et al · · 2016 · cited 224× · PMID 27094610 · DOI 10.2215/cjn.06890615
  2. Burden of Anemia in Chronic Kidney Disease: Beyond Erythropoietin.
    Hanna RM, Streja E, Kalantar-Zadeh K. · · 2021 · cited 114× · PMID 33123967 · DOI 10.1007/s12325-020-01524-6
  3. Treatment of Renal Anemia with Roxadustat: Advantages and Achievement.
    Li ZL, Tu Y, Liu BC. · · 2020 · cited 54× · PMID 32309288 · DOI 10.1159/000504850
  4. Iron metabolism and management: focus on chronic kidney disease.
    Agarwal AK. · · 2021 · cited 31× · PMID 33777495 · DOI 10.1016/j.kisu.2020.12.003
  5. Measurement properties of the Short Form-36 (SF-36) and the Functional Assessment of Cancer Therapy - Anemia (FACT-An) in patients with anemia associated with chronic kidney disease.
    Finkelstein FO, van Nooten F, Wiklund I, Trundell D, et al · · 2018 · cited 28× · PMID 29855366 · DOI 10.1186/s12955-018-0933-8
  6. Challenging patient phenotypes in the management of anaemia of chronic kidney disease.
    Pramod S, Goldfarb DS. · · 2021 · cited 7× · PMID 34331826 · DOI 10.1111/ijcp.14681
  7. Whether Prolyl Hydroxylase Blocker-Roxadustat-In the Treatment of Anemia in Patients with Chronic Kidney Disease Is the Future?
    Grzeszczak W, Szczyra D, Śnit M. · · 2021 · cited 5× · PMID 33567688 · DOI 10.3390/ijerph18041612
  8. Impact of C-reactive protein on the effect of Roxadustat for the treatment of anemia in chronic kidney disease: a systematic review of randomized controlled trials.
    Luo X, Li G, Yang H, Chen L, et al · · 2024 · cited 3× · PMID 38311719 · DOI 10.1186/s12882-024-03474-5

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Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing