Table 1.
Patient demographics and baseline characteristics
| Parameter | Molidustat (n = 153) | Darbepoetin alfa (n = 76) |
|---|---|---|
| Sex, n (%) | ||
| Male | 91 (59.5) | 49 (64.5) |
| Female | 62 (40.5) | 27 (35.5) |
| Age, years | 66.2 (10.3) | 64.8 (10.6) |
| Weight, kg | 58.52 (10.25) | 58.62 (12.38) |
| Height, cm | 160.86 (8.47) | 161.76 (8.44) |
| BMI, kg/m2 | 22.61 (3.34) | 22.25 (3.12) |
| Smoking history, n (%) | ||
| Never | 75 (49.0) | 33 (43.4) |
| Former | 60 (39.2) | 30 (39.5) |
| Current | 18 (11.8) | 13 (17.1) |
| Central Hb level, g/dl | 10.77 (0.64) | 10.84 (0.65) |
| Mean central Hb level during screening, g/dl | 10.79 (0.65) | 10.87 (0.64) |
| Previous ESA dose group,an (%) | ||
| Low | 152 (99.3) | 76 (100.0) |
| High | 1 (0.7) | 0 |
| Previous thromboembolic event,bn (%) | ||
| No | 141 (92.2) | 69 (90.8) |
| Yes | 12 (7.8) | 7 (9.2) |
| Main cause of CKD, n (%) | ||
| Diabetic nephropathy | 48 (31.4) | 24 (31.6) |
| Other | 93 (60.8) | 51 (67.1) |
| Chronic glomerulonephritis | 47 (30.7) | 25 (32.9) |
| Nephrosclerosis | 25 (16.3) | 15 (19.7) |
| Polycystic kidney disease | 13 (8.5) | 2 (2.6) |
| IgA nephropathy | 1 (0.7) | 3 (3.9) |
| Unknown | 12 (7.8) | 1 (1.3) |
| Duration of CKD, years | ||
| Mean (SD) | 12.067 (9.390) | 10.842 (8.841) |
| Median (range) | 9.593 (1.03–39.75) | 7.936 (1.10–36.79) |
| Duration of dialysis, years | ||
| Mean (SD) | 8.065 (7.588) | 7.706 (7.445) |
| Median (range) | 5.350 (0.31–34.39) | 5.677 (0.24–32.59) |
| Pulse rate, bpm | 72.2 (10.8) | 71.9 (11.4) |
| Systolic blood pressure, mmHg | 149.8 (17.2) | 148.1 (18.5) |
| Diastolic blood pressure, mmHg | 78.7 (11.2) | 79.7 (10.3) |
| Total iron binding capacity, μmol/l | 42.1 (6.6) | 42.1 (7.0) |
| Transferrin saturation, % | 29.2 (11.1) | 29.8 (10.0) |
| Hepcidin, ng/ml | 48.0 (40.1) | 48.9 (41.5) |
| Total iron, μg/dl | 67.6 (24.1) | 70.1 (27.1) |
| Ferritin, ng/ml | 118.7 (115.5) | 115.4 (119.1) |
| Vitamin B12, pmol/l | 336.6 (184.0) | 324.9 (172.7) |
| Folate, nmol/l | 224.8 (634.4) | 166.1 (596.5) |
| Serum C-reactive protein, mg/dl | 0.256 (0.623) | 0.217 (0.629) |
| Serum erythropoietin, IU/l | 11.378 (9.362) | 12.190 (13.462) |
BMI, body mass index; CKD, chronic kidney disease; ESA, erythropoiesis-stimulating agent; Hb, hemoglobin; IgA, immunoglobulin A.
Data presented are mean (SD) unless otherwise stated and are for the full analysis set.
a
Low previous ESA dose: darbepoetin alfa or epoetin beta pegol ≤50 μg/week and all doses of epoetin alfa or beta; high previous ESA dose: darbepoetin alfa or epoetin beta pegol >50 μg/week.
b
Previous thromboembolic event: previous myocardial infarction, pulmonary thromboembolism, stroke (excluding hemorrhagic stroke), or acute limb ischemia.