Table 2.
Demographics and BL characteristics (safety analysis set)
| Parameter | Category/statistic | Roxadustat (n = 391) | Placebo (n = 203) |
|---|---|---|---|
| Sex | Male | 169 (43.2 %) | 99 (48.8 %) |
| Female | 222 (56.8 %) | 104 (51.2 %) | |
| Age (years) | Median (range) | 62.0 (20–89) | 63.0 (26–90) |
| Race | White | 335 (85.7 %) | 182 (89.7 %) |
| Black or African American | 10 (2.6 %) | 3 (1.5 %) | |
| Asian | 9 (2.3 %) | 0 | |
| Other | 37 (9.5 %) | 18 (8.9 %) | |
| Region | Western Europe | 28 (7.2 %) | 16 (7.9 %) |
| Rest of World (mostly Eastern European) | 363 (92.8 %) | 187 (92.1 %) | |
| Hb (g/dL) | Mean (SD) | 9.08 (0.76) | 9.10 (0.72) |
| ≤8.0 g/dL | 32 (8.2 %) | 20 (9.9 %) | |
| >8.0 g/dL | 359 (91.8 %) | 183 (90.1 %) | |
| LDL cholesterol (mmol/L) | Mean (SD) | 2.99 (1.29) | 2.88 (1.14) |
| eGFR (mL/min/1.73 m2) | Mean (SD) | 16.5 (10.2) | 17.2 (11.7) |
| Median | 13.1 | 13.4 | |
| eGFR (mL/min/1.73 m2) categories | <10 | 119 (30.4 %) | 57 (28.1 %) |
| 10 to <15 | 102 (26.1 %) | 61 (30.0 %) | |
| 15 to <30 | 128 (32.7 %) | 58 (28.6 %) | |
| 30 to <45 | 34 (8.7 %) | 19 (9.4 %) | |
| 45 to <60 | 8 (2.0 %) | 7 (3.4 %) | |
| ≥60 | 0 | 1 (0.5)c | |
| CKD etiology | Diabetic nephropathy | 109 (27.9 %) | 66 (32.5) |
| Hypertensive nephropathy | 116 (29.7 %) | 58 (28.6) | |
| Glomerulonephritis, unspecified | 52 (13.3 %) | 23 (11.3) | |
| Pyelonephritis | 49 (12.5 %) | 24 (11.8) | |
| Polycystic kidney disease | 36 (9.2 %) | 21 (10.3) | |
| Other | 84 (21.5 %) | 41 (20.2) | |
| Weight, kg | Mean (SD) | 73.86 (16.49) | 76.50 (16.51) |
| Iron repletion at BL | Ferritin ≥100 ng/mL and TSAT ≥20% | 204 (52.2 %) | 109 (53.7 %) |
| hs-CRP, nmol/La | Mean (SD)b | 92.02 (228.72) | 87.37 (149.36) |
| Medianb | 29.15 | 29.25 | |
| ≤ULN | 245 (63.1 %) | 135 (66.8 %) | |
| >ULN | 143 (36.9 %) | 67 (33.2 %) | |
| Missing | 3 | 1 | |
| SBP, mmHg | Mean (SD) | 135 (13.62) | 134 (12.30) |
| DBP, mmHg | Mean (SD) | 77 (8.83) | 77 (8.68) |
| Cardiac and vascular disorders | Angina pectoris | 40 (10.2 %) | 26 (12.8 %) |
| Cardiac failure, chronic | 68 (17.4 %) | 44 (21.7 %) | |
| Hypertension | 379 (96.9 %) | 194 (95.6 %) | |
| Diabetes mellitus | Present | 131 (33.5 %) | 76 (37.4 %) |
| Statin use at BL | Yes | 119 (30.4 %) | 61 (30.0 %) |
hs-CRP, high-sensitivity C-reactive protein; ULN, upper limit of normal.
a
ULN = 47.6 nmol/L.
b
Based on data from FAS.
c
Patient met study criteria at screening.