Table 1.
Demographic and baseline characteristics
| Combined patient population | ||
|---|---|---|
| Ilofotase alfa (N = 330) | Placebo (N = 319) | |
| Sex, n (%) | ||
| Female | 124 (37.6) | 113 (35.4) |
| Male | 206 (62.4) | 206 (64.6) |
| Age, in years | 70 (62, 76) | 70 (61, 76) |
| Weight in kg | 84 (72, 100) | 82 (70, 100) |
| Height in cm | 172 (164, 178) | 170 (165, 178) |
| Body Mass Index in kg/m2 | 28.9 (25, 33.2) | 27.6 (24.6, 34) |
| Mechanical ventilation status, n (%) | ||
| Off | 84 (25.5%) | 74 (23.2) |
| On | 246 (74.5%) | 245 (76.8) |
| AKI stage at randomization, n (%) | ||
| 1 | 144 (43.6%) | 129 (40.4) |
| 2 | 93 (28.2%) | 105 (32.9) |
| 3 | 93 (28.2%) | 84 (26.3) |
| Missing | 0 | 1 (0.3) |
| Baseline eGFR1 | 31.2 (21.2, 43.3) | 30.6 (20.4, 42) |
| Pre-AKI eGFR | 74 (60.1, 88.3) | 73.9 (59.8, 89) |
| mSOFA | 9 (7, 10) | 9 (8, 11) |
| CRP | 260.5 (141.2, 341.2) | 235 (155.7, 321.3) |
| Lactate | 2.2 (1.5, 3.6) | 2.4 (1.5, 3.7) |
| PaO2/FiO2 ratio | 225.8 (146.3, 304.2) | 191.7 (134, 292.5) |
| Infection status | ||
| Proven | 156 (47.3) | 160 (50.2) |
| Suspected | 174 (52.7) | 159 (49.8) |
| Infection site | ||
| Abdominal | 120 (36.4) | 115 (36.1) |
| CNS | 7 (2.1) | 3 (0.9) |
| Other | 32 (9.7) | 34 (10.7) |
| Pulmonary | 97 (29.4) | 95 (29.8) |
| Skin or soft tissue | 24 (7.3) | 30 (9.4) |
| Unknown | 15 (4.5) | 18 (5.6) |
| Urinary tract | 35 (10.6) | 24 (7.5) |
| Pathogen proven/suspected | ||
| Proven | 132 (40) | 126 (39.5) |
| Suspected | 192 (58.2) | 190 (59.6) |
| Missing | 6 (1.8) | 3 (0.9) |
| Type of pathogen | ||
| Viral | 28 (8.5) | 18 (5.6) |
| Bacterial | 251 (76.1) | 239 (74.9) |
| Gram Positive | 77 (23.3) | 67 (21) |
| Gram Negative | 92 (27.9) | 82 (25.7) |
| Mixed | 49 (14.8) | 53 (16.6) |
| Missing | 33 (10) | 37 (11.6) |
| Missing | 51 (15.5) | 62 (19.4) |
Continuous variable: Median (IQR)
Patients have been analyzed according to treatment received
AKI acute kidney injury, CNS central nervous system, CRP C-reactive protein, eGFR estimated glomerular filtration rate, FiO2 fraction of inspired oxygen, mSOFA modified Sequential Organ Failure Assessment, PaO2 partial pressure of Oxygen
1AKI diagnosis value