Table 1:
Selected demographic baseline characteristics of patients receiving peritoneal dialysis and hemodialysis at baseline in the INNO2VATE trials (randomized population).
| Peritoneal dialysis | Hemodialysis | |||
|---|---|---|---|---|
| Vadadustat | Darbepoetin alfa | Vadadustat | Darbepoetin alfa | |
| Characteristic | (n = 152) | (n = 157) | (n = 1803) | (n = 1807) |
| Mean age, years (SD) | 54.8 (13.4) | 54.6 (13.9) | 58 (14.0) | 58.4 (13.9) |
| Sex, male, n (%) | 76 (50.0) | 86 (54.8) | 1019 (56.5) | 1031 (57.1) |
| Racial or ethnic group, n (%) | ||||
| White | 87 (57.2) | 86 (54.8) | 1175 (65.2) | 1153 (63.8) |
| Asian | 35 (23.0) | 37 (23.6) | 52 (2.9) | 70 (3.9) |
| Black or African American | 21 (13.8) | 24 (15.3) | 449 (24.9) | 454 (25.1) |
| Othera | 9 (5.9) | 10 (6.4) | 127 (7.0) | 130 (7.2) |
| Hispanic ethnic group, n (%) | ||||
| Hispanic/Latino | 52 (34.2) | 56 (35.7) | 699 (38.8) | 684 (37.9) |
| Not Hispanic/Latino | 96 (63.2) | 99 (63.1) | 1050 (58.2) | 1058 (58.6) |
| Region of enrollment, n (%) | ||||
| USA | 73 (48.0) | 90 (57.3) | 1112 (61.7) | 1097 (60.7) |
| Europe | 14 (9.2) | 5 (3.2) | 266 (14.8) | 292 (16.2) |
| Non-USA/Europe | 65 (42.8) | 62 (39.5) | 425 (23.6) | 418 (23.1) |
| Mean time since dialysis started, years (SD) | 2.8 (3.2) | 2.5 (3.0) | 3.7 (4.0) | 3.7 (4.0) |
| Disease history, n (%) | ||||
| Diabetes mellitus | 75 (49.3) | 87 (55.4) | 1000 (55.5) | 1007 (55.7) |
| Cardiovascular disease | 46 (30.3) | 56 (35.7) | 889 (49.3) | 948 (52.5) |
| NYHA CHF class, n (%) | ||||
| Class 0 (no CHF) or I | 141 (92.8) | 147 (93.6) | 1564 (86.7) | 1561 (86.4) |
| II or III | 11 (7.2) | 10 (6.4) | 239 (13.3) | 246 (13.6) |
| Mean BMI, kg/m2 (SD) | 28.0 (6.2) | 28.7 (8.1) | 28.5 (7.2) | 28.4 (7.0) |
| Mean hemoglobin concentration, g/dL (SD) | 10.1 (0.9) | 10.0 (0.9) | 10.2 (0.9) | 10.1 (0.9) |
| Iron-related parameters | ||||
| Hepcidin (ng/mL) | ||||
| Mean (SD) | 195.4 (145.6) | 189.5 (153.1) 139.3 | 186.7 (138.6) | 183.8 (133.3) |
| Median | 163.4 | 139.3 | 151.6 | 152.8 |
| Q1, Q3 | 80.3, 265.1 | 68.6, 264.3 | 85.5, 236.4 | 86.4, 234.8 |
| Ferritin (ng/mL) | ||||
| Mean (SD) | 585.9 (450.4) | 629.2 (507.5) | 831.8 (559.4) | 826.7 (534.4) |
| Median | 437.5 | 434.0 | 735.3 | 729.0 |
| Q1, Q3 | 256.8, 774.5 | 261.0, 895.5 | 404.0, 1135.0 | 418.5, 1121.0 |
| TIBC (µg/dL) | ||||
| Mean (SD) | 224.1 (36.2) | 222.5 (38.2) | 210.7 (36.6) | 212.2 (36.9) |
| Median | 222.8 | 218.0 | 206.5 | 210.0 |
| Q1, Q3 | 199.5, 247.3 | 195.0, 250.5 | 186.0, 231.0 | 187.0, 233.0 |
| Serum iron (µg/dL) | ||||
| Mean (SD) |
81.6 (28.6) |
87.1 (35.3) |
78.6 (29.1) |
78.2 (28.0) |
| Median | 76.0 | 77.0 | 73.0 | 72.0 |
| Q1, Q3 | 61.3, 97.8 | 65.5, 101.0 | 58.0, 92.0 | 59.0, 91.0 |
| TSAT (%) | ||||
| Mean (SD) | 36.9 (12.9) | 39.0 (13.9) | 37.5 (13.3) | 37.2 (13.1) |
| Median | 34.0 | 36.0 | 34.5 | 34.5 |
| Q1, Q3 | 28.0, 43.0 | 29.5, 43.5 | 28.0, 43.5 | 28.0, 43.0 |
a
Includes American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, multiple or not reported.
BMI, body mass index; CHF, congestive heart failure; SD, standard deviation.