Table 1.
Baseline demographics and clinical characteristics of study participants
| Characteristic | Lower-dose osocimab (n = 232) | Higher-dose osocimab (n = 224) | Placebo (n = 230) |
|---|---|---|---|
| Age, median (range) (years) | 61 (28–91) | 61 (25–90) | 60 (24–90) |
| Age group, n (%) | |||
| <60 years | 104 (44.8) | 103 (46.0) | 108 (47.0) |
| 60–75 years | 98 (42.2) | 84 (37.5) | 94 (40.9) |
| >75 years | 30 (12.9) | 37 (16.5) | 28 (12.2) |
| Male sex, n (%) | 143 (61.6) | 143 (63.8) | 150 (65.2) |
| Body mass indexa, n (%) | |||
| 25–30 kg m−2 | 62 (26.7) | 87 (38.8) | 93 (40.4) |
| ≥30 kg m−2 | 74 (31.9) | 65 (29.0) | 62 (27.0) |
| White, n (%) | 191 (82.3) | 185 (82.6) | 185 (80.4) |
| Geographic region, n (%) | |||
| Western Europe | 36 (15.5) | 37 (16.5) | 35 (15.2) |
| Eastern Europe | 133 (57.3) | 121 (54.0) | 123 (53.4) |
| Asia Pacific | 21 (9.0) | 19 (8.4) | 19 (8.2) |
| North America | 39 (16.8) | 37 (16.5) | 37 (16.1) |
| Australia and Israel | 3 (1.2) | 10 (4.4) | 16 (6.9) |
| Dialysis duration, median (interquartile range) years | 4.05 (2.0–7.2) | 4.0 (2.0–7.5) | 3.85 (1.8–7.0) |
| Dialysis access, n (%) | |||
| Fistula | 191 (82.3) | 180 (80.4) | 189 (82.2) |
| Graft | 22 (9.5) | 20 (8.9) | 13 (5.7) |
| Catheter | 19 (8.2) | 24 (10.7) | 28 (12.2) |
| Heparin use during dialysis, n (%) | 221 (95.3) | 218 (97.3) | 218 (94.8) |
| Etiology of kidney disease, n (%) | |||
| Diabetes | 65 (28.0) | 53 (23.6) | 59 (25.6) |
| Hypertension | 51 (22.0) | 67 (30.0) | 50 (21.7) |
| Glomerulonephritis | 32 (13.8) | 30 (13.4) | 33 (14.3) |
| Pyelonephritis | 11 (4.7) | 10 (4.5) | 10 (4.3) |
| Polycystic kidney disease | 23 (9.9) | 23 (10.3) | 21 (9.1) |
| Other | 50 (21.5) | 41 (18.3) | 57 (24.8) |
| Diabetes, n (%) | 90 (38.8) | 82 (36.6) | 87 (37.8) |
| Hypertension, n (%) | 213 (91.8) | 212 (94.6) | 215 (93.5) |
| Coronary heart disease, n (%) | 56 (24.1) | 61 (27.2) | 47 (20.4) |
| Myocardial infarction, n (%) | 17 (7.3) | 15 (6.7) | 11 (4.8) |
| Peripheral artery disease, n (%) | 18 (7.8) | 23 (10.3) | 22 (9.6) |
| Stroke, n (%) | 12 (5.1) | 18 (7.7) | 18 (7.7) |
| Atrial fibrillation, n (%) | 15 (6.5) | 17 (7.6) | 14 (6.1) |
| Previous cardiovascular eventb, n (%) | 37 (15.9) | 43 (19.2) | 40 (17.4) |
| Atherosclerosisc, n (%) | 81 (34.9) | 86 (38.4) | 82 (35.7) |
| History of venous thromboembolism, n (%) | 8 (3.4) | 10 (4.5) | 10 (4.3) |
| Platelet count, mean (s.d.) × 109 l−1 | 209 (62) | 209 (56) | 212 (58) |
| Hemoglobin, median (interquartile range) (mg dl−1) | 10.9 (10.2–11.8) | 11.1 (10.4–11.8) | 11.0 (10.4–11.7) |
| Low-dose aspirin, n (%) | 97 (41.8) | 95 (42.4) | 98 (42.6) |
| Duration of study drug administration, median (interquartile range) (months) | 9.1 (7.0–11.7) | 9.2 (7.1–11.7) | 9.0 (7.1–11.4) |
| Length of study, n (%) | |||
| ≤6 months | 37 (15.9) | 33 (14.7) | 26 (11.3) |
| >6–9 months | 76 (32.8) | 73 (32.6) | 89(38.7) |
| >9 months | 119 (51.3) | 118 (52.7) | 115 (50.0) |
Percentages may not total 100 because of rounding.
aBody mass index is the weight in kilograms divided by the square of the height in meters.
bPrevious cardiovascular events include stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis and pulmonary embolism.
cAtherosclerosis was defined as a history of ischemic stroke, transient ischemic attack, unstable angina, myocardial infarction, peripheral artery disease or aortic aneurysm.