Table 1.
Demographics and baseline characteristics (safety analysis population)
| Statistics | Desidustat oral tablet (N = 196) | Epoetin alfa injection (N = 196) | Overall (N = 392) | |
|---|---|---|---|---|
| Age, years | Mean ± SD | 51.02±13.97 | 50.91±13.48 | 50.96±13.71 |
| Median (min, max) | 52.50 (18.00, 77.00) | 52.00 (21.00, 91.00) | 52.00 (18.00, 91.00) | |
| Gender, n (%) | Female | 61 (31.12) | 62 (31.63) | 123 (31.38) |
| Male | 135 (68.88) | 134 (68.37) | 269 (68.62) | |
| Race, n (%) | Asian | 196 (100.0) | 196 (100.0) | 392 (100.0) |
| Ethnicity, n (%) | South Asian | 196 (100.0) | 196 (100.0) | 392 (100.0) |
| Weight, kg | Mean ± SD | 58.93±13.37 | 60.82±13.36 | 59.87±13.38 |
| Median (min, max) | 57.00 (34.00, 112.00) | 59.20 (31.10, 104.00) | 58.00 (31.10, 112.00) | |
| Height, cm | Mean ± SD | 162.02±9.87 | 162.95±8.78 | 162.49±9.34 |
| Median (min, max) | 162.00 (134.00, 192.00) | 164.00 (141.00, 188.00) | 163.00 (134.00, 192.00) | |
| BMI, kg/m2 | Mean ± SD | 22.43±4.96 | 22.90±5.01 | 22.66±4.99 |
| Median (min, max) | 21.85 (11.90, 46.60) | 22.20 (14.10, 43.10) | 21.95 (11.90, 46.60) | |
| Medical history, n (%) | ||||
| Diabetes mellitus | − | 71 (36.22) | 70 (35.71) | 141 (35.96) |
| Hypertension | − | 181 (92.35) | 178 (90.82) | 359 (91.58) |
| Cardiac disorders | − | 10 (5.10) | 7 (3.57) | 17 (4.34) |
| Laboratory parameters | ||||
| Hemoglobin, g/dL | Mean ± SD | 9.61±0.99 | 9.55±1.37 | − |
| Ferritin, ng/mL | Mean ± SD | 1,209.72±1,133.85 | 1,188.53±1,170.54 | − |
| TSAT, % | Mean ± SD | 37.60±18.49 | 35.88±16.47 | − |
| CRP, mg/L | Mean ± SD | 7.88±6.76 | 7.51±6.79 | − |
| Lipids and lipoprotein, mg/dL | ||||
| LDL cholesterol | Mean ± SD | 77.41±31.66 | 80.34±32.60 | − |
| HDL cholesterol | Mean ± SD | 40.92±14.12 | 39.06±12.47 | − |
| VLDL cholesterol | Mean ± SD | 27.04±17.59 | 27.85±17.92 | − |
| Total cholesterol | Mean ± SD | 137.05±37.58 | 137.41±35.91 | − |
| Apolipoprotein-A1 | Mean ± SD | 110.37±21.62 | 109.30±18.40 | − |
| Apolipoprotein-B | Mean ± SD | 75.05±24.98 | 76.76±24.32 | − |
| Lipoprotein (a) | Mean ± SD | 38.74±38.37 | 42.79±35.70 | − |
| Triglycerides | Mean ± SD | 135.03±87.87 | 139.27±89.59 | − |
| Potassium, mmol/L | Mean ± SD | 5.21±0.94 | 5.36±1.07 | − |
| Blood pressure, mm Hg | ||||
| Systolic | Mean ± SD | 143.06±16.71 | 143.15±14.98 | − |
| Diastolic | Mean ± SD | 82.01±10.05 | 82.21±9.67 | − |
BMI, body mass index; CRP, C-reactive protein; max, maximum; min, minimum; eGFR, estimated glomerular filtration rate; HDL, high-density lipoprotein; LDL, low-density lipoprotein; VEGF, vascular endothelial growth factor; VLDL, very low-density lipoprotein; N, number of subjects in the mITT population in each treatment group; n, number of subjects in each treatment group at specific visit; SD, standard deviation.