Table 1.
Baseline patient characteristics (ITT and mITT populations)
| Characteristic | Vadadustat |
Placebo | ||||
|---|---|---|---|---|---|---|
| 240 mg | 370 mg | 500 mg | 630 mg | Total | ||
| Safety population (ITT), n | 18 | 18 | 17 | 19 | 72 | 19 |
| Age, years | 64.2 (12.2) | 68.9 (7.8) | 64.7 (9.5) | 64.9 (8.8) | 65.7 (9.7) | 64.9 (10.0) |
| Women | 9 (50) | 7 (39) | 13 (77) | 7 (37) | 36 (50) | 12 (63) |
| Race | ||||||
| Black/African American | 6 (33) | 4 (22) | 4 (24) | 7 (37) | 21 (29) | 3 (16) |
| White/Caucasian | 10 (56) | 13 (72) | 13 (77) | 9 (47) | 45 (63) | 14 (74) |
| Other | 2 (11) | 1 (6) | 0 (0) | 3 (16) | 6 (8) | 2 (11) |
| Weight, kg | 84.5 (18.4) | 84.4 (17.1) | 83.9 (18.3) | 86.2 (23.2) | 84.8 (19.1) | 81.9 (20.9) |
| BMI, kg/m2 | 30.6 (4.2) | 29.8 (5.6) | 32.1 (6.8) | 29.1 (6.5) | 30.3 (5.8) | 29.8 (6.6) |
| eGFR, mL/min/1.73 m2 | 22.3 (12.1) | 25.0 (11.2) | 25.3 (9.2) | 24.9 (12.3) | 24.4 (11.1) | 25.2 (11.1) |
| CKD stage | ||||||
| 3 | 5 (28) | 4 (22) | 4 (24) | 5 (26) | 18 (25) | 5 (26) |
| 4 | 13 (72) | 14 (78) | 13 (77) | 14 (74) | 54 (75) | 14 (74) |
| Diabetes mellitus | 14 (78) | 12 (67) | 12 (71) | 13 (68) | 51 (71) | 13 (68) |
| History of ESA use | 6 (33) | 6 (33) | 4 (24) | 2 (11) | 18 (25) | 7 (37) |
| Efficacy population (mITT), n | 18 | 16 | 17 | 19 | 70 | 19 |
| Hb, g/dL | 9.47 (0.80) | 9.96 (0.68) | 9.96 (0.64) | 9.70 (0.81) | 9.76 (0.75) | 9.86 (0.69) |
| TIBC, µg/dL | 219.4 (39.4) | 249.9 (55.4) | 243.6 (45.4) | 231.8 (36.2) | 236.0 (45.2) | 243.1 (40.0) |
| Ferritin, ng/mL | 349.5 (226.3) | 257.8 (213.2) | 322.8 (312.2) | 240.2 (142.1) | 291.4 (228.7) | 200.8 (116.0) |
| Hepcidin, ng/mL | 326.3 (222.0) | 241.0 (158.9) | 251.1 (112.4) | 282.8 (239.3) | 276.8 (191.3) | 258.3 (144.1) |
ITT, intent-to-treat; mITT, modified ITT; Hb, hemoglobin; BMI, body mass index; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ESA, erythropoiesis-stimulating agent; TIBC, total iron binding capacity. Values are n (%) or mean (SD), as applicable.