Table 1.
Baseline characteristics of participants in three phase 3 studies of roxadustat with non–dialysis-dependent CKD (ITT)
| Characteristics | Roxadustat (n=2391) | Placebo (n=1886) |
| Age (yr), mean (SD)a | 62 (14) | 63 (14) |
| Male sex, n (%) | 974 (41) | 832 (44) |
| Weight (kg), mean (SD) | 71 (18) | 71 (19) |
| Hemoglobin (g/dl), mean (SD) | 9.1 (0.7) | 9.1 (0.7) |
| <8.0, n (%) | 204 (9) | 164 (9) |
| ≥8.0, n (%) | 2187 (92) | 1722 (91) |
| eGFR (ml/min per 1.73 m2), mean (SD) | 20 (12) | 20 (12) |
| <10.0, n (%) | 481 (20) | 359 (19) |
| 10.0 to <15.0, n (%) | 526 (22) | 452 (24) |
| 15.0 to <30.0, n (%) | 954 (40) | 724 (38) |
| ≥30.0, n (%) | 430 (18) | 351 (19) |
| hs-CRP (mg/L), mean (SD) b | 7.4 (17.4) | 7.2 (16.7) |
| Median (min–max) | 2.2 (0.1–338) | 2.2 (0.1–187) |
| Greater than upper limit of normal, n (%) | 526 (22) | 357 (19) |
| LDL cholesterol (mg/dl), mean (SD) | 99 (44) | 95 (42) |
| Iron repletion status, n (%) | ||
| Ferritin ≥100 ng/ml and TSAT ≥20% | 1433 (60) | 1127 (60) |
| Diabetes mellitus, n (%) | 1337 (56) | 1096 (58) |
ITT, intention-to-treat population; hs-CRP, high-sensitivity C-reactive protein; min, minimum; max, maximum; TSAT, transferrin saturation.
a
Age was calculated in years from birth date to date of informed consent or first-dose date.
b
Upper limit of normal for hs-CRP was defined as 4.6 mg/l.