Table 3.
Demographics and baseline characteristics (safety analysis set)
| Parameter | Roxadustat (n = 414) | ESA (n = 420) | Total (N = 834) |
|---|---|---|---|
| Sex, male, n (%) | 245 (59.2) | 235 (56.0) | 480 (57.6) |
| Race, n (%) | |||
| White | 405 (97.8) | 407 (96.9) | 812 (97.4) |
| Black | 6 (1.4) | 6 (1.4) | 12 (1.4) |
| Asian | 1 (0.2) | 3 (0.7) | 4 (0.5) |
| Other | 2 (0.5) | 4 (1.0) | 6 (0.7) |
| Age, years | 61.0 (13.8) | 61.8 (13.4) | 61.4 (13.6) |
| Weight, kg | 76.29 (15.88) | 76.18 (17.25) | 76.23 (16.58) |
| BMI, kg/m2 | 26.87 (4.86) | 26.95 (5.59) | 26.91 (5.24) |
| Region, n (%) | |||
| Western Europe | 86 (20.8) | 90 (21.4) | 176 (21.1) |
| Central and Eastern Europe | 328 (79.2) | 330 (78.6) | 658 (78.9) |
| Country, n (%) | |||
| Bulgaria | 69 (16.7) | 87 (20.7) | 156 (18.7) |
| Hungary | 63 (15.2) | 73 (17.4) | 136 (16.3) |
| Russian Federation | 52 (12.6) | 46 (11.0) | 98 (11.8) |
| Serbia | 51 (12.3) | 35 (8.3) | 86 (10.3) |
| Croatia | 28 (6.8) | 31 (7.4) | 59 (7.1) |
| Romania | 20 (4.8) | 20 (4.8) | 40 (4.8) |
| Italy | 19 (4.6) | 20 (4.8) | 39 (4.7) |
| Poland | 18 (4.3) | 11 (2.6) | 29 (3.5) |
| Spain | 17 (4.1) | 12 (2.9) | 29 (3.5) |
| Germany | 15 (3.6) | 19 (4.5) | 34 (4.1) |
| Slovakia | 15 (3.6) | 17 (4.0) | 32 (3.8) |
| Portugal | 11 (2.7) | 6 (1.4) | 17 (2.0) |
| Belgium | 11 (2.7) | 20 (4.8) | 31 (3.7) |
| Other | 25 (6.0) | 23 (5.5) | 48 (5.8) |
| Hb, g/dL | 10.75 (0.62) | 10.78 (0.62) | 10.76 (0.62) |
| LDL cholesterola, mmol/L | 2.750 (1.017) | 2.644 (1.015) | 2.697 (1.017) |
| Previous ESA treatment, n (%) | |||
| Epoetin | 256 (61.8) | 257 (61.2) | 513 (61.5) |
| Darbepoetin alfa | 158 (38.2) | 163 (38.8) | 321 (38.5) |
| Previous ESA dose/weekb, n (%) | |||
| ≤ 200 IU/kg epoetin or ≤ 1 µg/kg darbepoetin alfa | 406 (98.1) | 407 (96.9) | 813 (97.5) |
| > 200 IU/kg epoetin or > 1 µg/kg darbepoetin alfa | 8 (1.9) | 13 (3.1) | 21 (2.5) |
| Previous ESA dose/weekb, n (%) | |||
| < 25 µg darbepoetin alfa or < 5000 IU epoetin | 222 (53.6) | 189 (45.0) | 411 (49.3) |
| 25 to < 40 µg darbepoetin alfa or 5000 to < 8000 IU epoetin | 111 (26.8) | 133 (31.7) | 244 (29.3) |
| 40 to < 80 µg darbepoetin alfa or 8000 to < 16,000 IU epoetin | 77 (18.6) | 93 (22.1) | 170 (40.4) |
| ≥ 80 µg darbepoetin alfa or ≥ 16,000 IU epoetin | 4 (1.0) | 5 (1.2) | 9 (1.1) |
| Time from CKD diagnosis, years | 8.81 (7.08) | 8.29 (6.65) | 8.55 (6.87) |
| CKD etiology, n (%) | |||
| Hypertensive nephropathy | 124 (30.0) | 120 (28.6) | 244 (29.3) |
| Diabetic nephropathy | 74 (17.9) | 95 (22.6) | 169 (20.3) |
| Glomerulonephritis unspecified | 56 (13.5) | 56 (13.3) | 112 (13.4) |
| Pyelonephritis | 48 (11.6) | 40 (9.5) | 88 (10.6) |
| Baseline dialysis type, n (%) | |||
| Hemodialysis | 379 (91.5) | 405 (96.4) | 784 (94.0) |
| Peritoneal dialysis | 35 (8.5) | 15 (3.6) | 50 (6.0) |
| Baseline CRP (nmol/L) | |||
| ≤ ULN | 210 (50.7) | 226 (53.8) | 436 (52.3) |
| > ULN | 204 (49.3) | 194 (46.2) | 398 (47.7) |
| Dialysis vintage, years | |||
| Mean (SD) | 4.35 (4.18) | 4.10 (3.65) | 4.22 (3.92) |
| Median (min, max) | 2.89 (0.35, 27.04) | 2.97 (0.33, 20.86) | 2.95 (0.33, 27.04) |
| Iron repletion at baseline, n (%) | |||
| Ferritin ≥ 100 ng/mL and TSAT ≥ 20% | 355 (86.0) | 366 (87.1) | 721 (86.6) |
| Ferritin < 100 ng/mL or TSAT < 20% | 58 (14.0) | 54 (12.9) | 112 (13.4) |
| Blood pressurea, mmHg | |||
| Systolic | 135.2 (17.6) | 136.9 (18.9) | 136.0 (18.3) |
| Diastolic | 75.2 (11.0) | 74.3 (11.2) | 74.8 (11.1) |
| History of cardiovascular, cerebrovascular, or thromboembolic diseasesc, n (%) | 169 (40.8) | 201 (47.9) | 370 (44.4) |
| Type 2 diabetes mellitus, n (%) | 89 (21.5) | 127 (30.2) | 216 (25.9) |
| History of diabetes, n (%) | 104 (25.1) | 133 (31.7) | 237 (28.4) |
Data are reported as mean (SD) unless otherwise indicated
BMI body mass index, CKD chronic kidney disease, ESA erythropoiesis-stimulating agent, Hb hemoglobin, LDL low-density lipoprotein, SD standard deviation, TSAT transferrin saturation, ULN upper limit of normal
aData from all randomized patients
bAverage weekly ESA dose in the 4 weeks prior to randomization
cDerived and based on selected preferred terms from the electronic clinical record form used for the analyses