Patient demographics
| . | Randomized patients . | ||
|---|---|---|---|
| 0.25 mg/kg AB023 (n = 8) . | 0.5 mg/kg AB023 (n = 8) . | Placebo (n = 8) . | |
| Age, mean (SD), y | 55.8 (7.6) | 53.4 (5.0) | 52.5 (9.2) |
| Women, n (%) | 1 (12.5) | 3 (37.5) | 1 (12.5) |
| Men, n (%) | 7 (87.5) | 5 (62.5) | 7 (87.5) |
| Race | |||
| White | 0 (0) | 1 (12.5) | 2 (25) |
| Black | 8 (100) | 7 (87.5) | 6 (75) |
| Weight, mean (SD), kg | 88.3 (17.1) | 82.9 (19.4) | 78.8 (10.4) |
| BMI, mean (SD) | 27.8 (3.9) | 27.9 (5.4) | 24.7 (2.9) |
| Smoker, n (%) | 1 (12.5) | 2 (25) | 1 (12.5) |
| Time on hemodialysis, mean (SD), y | 9.6 (6.7) | 7.6 (4.9) | 8 (5.3) |
| Primary cause of kidney failure, n (%) | |||
| Hypertension | 6 (75) | 5 (62.5) | 4 (50) |
| Diabetes | 0 | 2 (25) | 0 (0) |
| Polycystic kidney disease | 1 (12.5) | 0 (0) | 0 (0) |
| Multiple | 1 (12.5) | 1 (12.5) | 4 (50) |
| aPTT at screening, mean, (SD), s | 36.5 (3.6) | 39.3 (5.6) | 35.0 (4.1) |
| aPTT above normal range, n (%) | 3 (37.5) | 6 (75) | 2 (25) |
| Platelet count <150 000 at check-in, n (%) | 3 (37.5) | 3 (37.5) | 4 (50) |
| Platelet count at screening, mean (SD), K/µL | 220.1 (137.5) | 180.1 (72.3) | 164.4 (69.6) |
| Hemoglobin at screening, mean (SD), g/dL | 12.7 (1.9) | 12.1 (2.1) | 11.6 (0.6) |
| Blood pressure at screening, mean (SD), mm Hg | |||
| Systolic | 121 (27) | 135 (17) | 149 (30) |
| Diastolic | 76 (10) | 73 (12) | 83 (10) |
| Comorbidities, n (%) | |||
| Hypertension | 8 (100) | 8 (100) | 8 (100) |
| Diabetes | 1 (12.5) | 4 (50) | 5 (62.5) |
| Cardiovascular disease* | 2 (25) | 4 (50) | 2 (25) |
| History of extremity amputation | 1 (12.5) | 2 (25) | 0 (0) |
| Cancer | 0 (0) | 0 (0) | 1 (12.5) |
| . | Randomized patients . | ||
|---|---|---|---|
| 0.25 mg/kg AB023 (n = 8) . | 0.5 mg/kg AB023 (n = 8) . | Placebo (n = 8) . | |
| Age, mean (SD), y | 55.8 (7.6) | 53.4 (5.0) | 52.5 (9.2) |
| Women, n (%) | 1 (12.5) | 3 (37.5) | 1 (12.5) |
| Men, n (%) | 7 (87.5) | 5 (62.5) | 7 (87.5) |
| Race | |||
| White | 0 (0) | 1 (12.5) | 2 (25) |
| Black | 8 (100) | 7 (87.5) | 6 (75) |
| Weight, mean (SD), kg | 88.3 (17.1) | 82.9 (19.4) | 78.8 (10.4) |
| BMI, mean (SD) | 27.8 (3.9) | 27.9 (5.4) | 24.7 (2.9) |
| Smoker, n (%) | 1 (12.5) | 2 (25) | 1 (12.5) |
| Time on hemodialysis, mean (SD), y | 9.6 (6.7) | 7.6 (4.9) | 8 (5.3) |
| Primary cause of kidney failure, n (%) | |||
| Hypertension | 6 (75) | 5 (62.5) | 4 (50) |
| Diabetes | 0 | 2 (25) | 0 (0) |
| Polycystic kidney disease | 1 (12.5) | 0 (0) | 0 (0) |
| Multiple | 1 (12.5) | 1 (12.5) | 4 (50) |
| aPTT at screening, mean, (SD), s | 36.5 (3.6) | 39.3 (5.6) | 35.0 (4.1) |
| aPTT above normal range, n (%) | 3 (37.5) | 6 (75) | 2 (25) |
| Platelet count <150 000 at check-in, n (%) | 3 (37.5) | 3 (37.5) | 4 (50) |
| Platelet count at screening, mean (SD), K/µL | 220.1 (137.5) | 180.1 (72.3) | 164.4 (69.6) |
| Hemoglobin at screening, mean (SD), g/dL | 12.7 (1.9) | 12.1 (2.1) | 11.6 (0.6) |
| Blood pressure at screening, mean (SD), mm Hg | |||
| Systolic | 121 (27) | 135 (17) | 149 (30) |
| Diastolic | 76 (10) | 73 (12) | 83 (10) |
| Comorbidities, n (%) | |||
| Hypertension | 8 (100) | 8 (100) | 8 (100) |
| Diabetes | 1 (12.5) | 4 (50) | 5 (62.5) |
| Cardiovascular disease* | 2 (25) | 4 (50) | 2 (25) |
| History of extremity amputation | 1 (12.5) | 2 (25) | 0 (0) |
| Cancer | 0 (0) | 0 (0) | 1 (12.5) |
Includes cardiac surgery, stent placement, coronary artery disease, aneurism, congestive heart failure, stroke, and myocardial infarction.