Table 1.
Subject demographics and baseline characteristics (ITT population)
| Vadadustat dose cohorts |
||||
|---|---|---|---|---|
| Characteristic | 300 mg QD | 450 mg QD | 450 mg TIW | All subjects |
| (n = 30) | (n = 33) | (n = 31) | (n = 94) | |
| Age (years) | 55.5 ± 12.4 | 59.4 ± 11.6 | 57.8 ± 8.3 | 57.6 ± 10.9 |
| Sex | ||||
| Male | 17 (56.7) | 18 (54.5) | 19 (61.3) | 54 (57.4) |
| Female | 13 (43.3) | 15 (45.5) | 12 (38.7) | 40 (42.6) |
| Weight (kg) | 82.7 ± 22.7 | 82.1 ± 19.7 | 84.2 ± 16.5 | 83.0 ± 19.6 |
| BMI (kg/m2) | 29.8 ± 7.7 | 29.6 ± 6.0 | 29.2 ± 5.4 | 29.5 ± 6.4 |
| Race | ||||
| Black/African American | 6 (20.0) | 9 (27.3) | 9 (29.0) | 24 (25.5) |
| White/Caucasian | 24 (80.0) | 21 (63.6) | 19 (61.3) | 64 (68.1) |
| Other | 0 (0.0) | 3 (9.1) | 3 (9.7) | 6 (6.4) |
| Etiology of CKD* | ||||
| Diabetes | 16 (53.3) | 23 (69.7) | 21 (67.7) | 60 (63.8) |
| Hypertension & large vessel disease | 15 (50.0) | 17 (51.5) | 21 (67.7) | 53 (56.4) |
| Other | 17 (56.67) | 18 (54.55) | 12 (38.71) | 47 (50.00) |
| Medical History* | ||||
| Diabetes | 18 (60.0) | 25 (75.8) | 19 (61.3) | 62 (66.0) |
| Hypertension | 28 (93.3) | 33 (100.0) | 31 (100.0) | 92 (97.9) |
| Time since initiation of dialysis (years [10th, 90th percentiles]) | 4.9 (0.9, 11.6) | 4.9 (0.7, 11.6) | 3.9 (0.5, 6.9) | 4.6 (0.8, 10.8) |
| Baseline epoetin alfa dose (U/week) | 5940 ± 4387 | 8022 ± 5208 | 8059 ± 6519 | 7370 ± 5478 |
| Blood pressure: systolic (mmHg) | 138.9 ± 18.4 | 147.8 ± 25.3 | 147.3 ± 18.2 | 144.8 ± 21.2 |
| Blood pressure: diastolic (mmHg) | 70.9 ± 11.6 | 78.3 ± 12.4 | 74.8 ± 10.7 | 74.8 ± 11.6 |
| Heart rate (beats/min) | 77.1 ± 10.0 | 80.5 ± 13.6 | 74.9 ± 10.2 | 77.6 ± 11.6 |
| Hb (g/dL) | 10.4 ± 0.7 | 10.6 ± 0.6 | 10.5 ± 0.5 | 10.5 ± 0.6 |
| Iron (µg/dL) | 70.6 ± 26.3 | 66.6 ± 23.7 | 75.4 ± 32.3 | 70.8 ± 27.5 |
| TIBC (µg/dL) | 204.5 ± 39.7 | 196.7 ± 29.4 | 188.8 ± 32.3 | 196.6 ± 34.2 |
| Ferritin (ng/mL) | 762.9 ± 470.5 | 782.0 ± 465.2 | 807.8 ± 431.0 | 784.4 ± 451.4 |
| TSAT (%) | 34.6 ± 11.6 | 33.7 ± 11.1 | 37.5 ± 13.3 | 35.2 ± 12.0 |
| Hepcidin (ng/mL) | 102.6 ± 58.9 | 119.6 ± 54.8 | 105.4 ± 46.8 | 109.5 ± 53.7 |
| C-reactive protein (mg/dL) | 1.2 ± 2.4 | 1.1 ± 1.5 | 1.6 ± 3.3 | 1.3 ± 2.4 |
| Serum bicarbonate (mEq/l) | 17.68 ± 2.88 | 19.84 ± 2.87 | 19.26 ± 2.78 | 18.96 ± 2.96 |
| CHr (pg) | 32.39 ± 1.80 | 32.12 ± 1.68 | 30.99 ± 2.37 | 31.84 ± 2.04 |
Data are presented as n (%) or mean ± SD, with the exception of vintage, reported as median (10%, 90% range)
*
Patients could have >1 disease etiology and >1 medical condition (medical history)
BMI, body mass index; CHr, reticulocyte Hb content; CKD, chronic kidney disease; Hb, hemoglobin; QD, once daily; SD, standard deviation; TIBC, total iron binding capacity; TIW, three times per week; TSAT, transferrin saturation.