Table 1.
Subject characteristics
| a. Correction group | ||||||
| Characteristic | Placebo (n = 23) |
Enarodustat 2 mg (n = 24) |
Enarodustat 4 mg (n = 24) |
Enarodustat 6 mg (n = 23) |
Total (n = 94) |
|
|---|---|---|---|---|---|---|
| Age, years, mean (SD) | 65.3 (14.7) | 71.6 (10.4) | 70.4 (8.1) | 63.6 (15.2) | 67.8 (12.6) | |
| Gender, n (%) | ||||||
| Male | 9 (39.1) | 11 (45.8) | 12 (50.0) | 16 (69.6) | 48 (51.1) | |
| Female | 14 (60.9) | 13 (54.2) | 12 (50.0) | 7 (30.4) | 46 (48.9) | |
| Body weight, kg, mean (SD) | 61.0 (16.0) | 57.3 (11.8) | 58.7 (12.3) | 60.2 (9.4) | 59.3 (12.5) | |
| eGFR, mL/min/1.73 m2, mean (SD) | 16.0 (6.4) | 18.5 (11.0) | 17.2 (7.4) | 18.7 (7.5) | 17.6 (8.2) | |
| <15, n (%) | 11 (47.8) | 13 (54.2) | 9 (37.5) | 7 (30.4) | 40 (42.6) | |
| ≤15 to <30, n (%) | 11 (47.8) | 8 (33.3) | 13 (54.2) | 14 (60.9) | 46 (48.9) | |
| ≤30, n (%) | 1 (4.3) | 3 (12.5) | 2 (8.3) | 2 (8.7) | 8 (8.5) | |
| Primary cause of CKD, n (%) | ||||||
| Chronic glomerulonephritis | 8 (34.8) | 10 (41.7) | 6 (25.0) | 6 (26.1) | 30 (31.9) | |
| Diabetic nephropathy | 3 (13.0) | 7 (29.2) | 6 (25.0) | 10 (43.5) | 26 (27.7) | |
| Nephrosclerosis | 6 (26.1) | 4 (16.7) | 5 (20.8) | 3 (13.0) | 18 (19.1) | |
| Other | 6 (26.1) | 3 (12.5) | 7 (29.2) | 4 (17.4) | 20 (21.3) | |
| Oral iron, n (%) | 5 (21.7) | 2 (8.3) | 2 (8.3) | 1 (4.3) | 10 (10.6) | |
| b.Conversion group | |||||
|---|---|---|---|---|---|
| Characteristic | Placebo (n = 24) |
Enarodustat 2 mg (n = 26) |
Enarodustat 4 mg (n = 27) |
Enarodustat 6 mg (n = 26) |
Total (n = 103) |
| Age, years, mean (SD) | 66.2 (11.9) | 67.8 (9.3) | 67.5 (11.8) | 68.8 (11.2) | 67.6 (11.0) |
| Gender, n (%) | |||||
| Male | 13 (54.2) | 15 (57.7) | 14 (51.9) | 12 (46.2) | 54 (52.4) |
| Female | 11 (45.8) | 11 (42.3) | 13 (48.1) | 14 (53.8) | 49 (47.6) |
| Body weight, kg, mean (SD) | 57.1 (11.2) | 62.8 (10.5) | 57.0 (11.6) | 53.0 (10.2) | 57.5 (11.3) |
| eGFR, mL/min/1.73 m2, mean (SD) | 16.4 (8.1) | 14.9 (5.8) | 14.3 (5.9) | 17.2 (7.3) | 15.7 (6.8) |
| <15, n (%) | 15 (62.5) | 13 (50.0) | 17 (63.0) | 13 (50.0) | 58 (56.3) |
| ≤15 to <30, n (%) | 5 (20.8) | 13 (50.0) | 9 (33.3) | 10 (38.5) | 37 (35.9) |
| ≤30, n (%) | 4 (16.7) | 0 (0.0) | 1 (3.7) | 3 (11.5) | 8 (7.8) |
| Primary disease of CKD, n (%) | |||||
| Chronic glomerulonephritis | 11 (45.8) | 10 (38.5) | 4 (14.8) | 11 (42.3) | 36 (35.0) |
| Diabetic nephropathy | 5 (20.8) | 6 (23.1) | 7 (25.9) | 3 (11.5) | 21 (20.4) |
| Nephrosclerosis | 2 (8.3) | 7 (26.9) | 11 (40.7) | 6 (23.1) | 26 (25.2) |
| Other | 6 (25.0) | 3 (11.5) | 5 (18.5) | 6 (23.1) | 20 (19.4) |
| Prior ESA, n (%) | |||||
| rHuEPO | 1 (4.2) | 2 (7.7) | 2 (7.4) | 3 (11.5) | 8 (7.8) |
| Darbepoetinalfa | 12 (50.0) | 9 (34.6) | 14 (51.9) | 11 (42.3) | 46 (44.7) |
| Epoetin beta pegol | 11 (45.8) | 15 (57.7) | 11 (40.7) | 12 (46.2) | 49 (47.6) |
| Prior ESA dose per week | |||||
| rHuEPO, IU, mean | 3,000 | 1,500 | 3,000 | 2,500 | 2,437.5 (776.3) |
| Darbepoetin alfa,µg, mean (SD) | 13.3 (6.3) | 13.1 (7.9) | 13.9 (6.3) | 16.8 (11.2) | 14.3 (7.9) |
| Epoetin beta pegol,µg, mean (SD) | 68.2 (47.6) | 71.7 (49.9) | 56.8 (31.8) | 58.3 (22.2) | 64.3 (39.5) |
| Oral iron, n (%) | 3 (12.5) | 3 (11.5) | 2 (7.4) | 4 (15.4) | 12 (11.7) |
Body weight and eGFR on Scr Visit 1 are shown. The number of patients taking oral iron at Scr Visit 1 is shown. CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ESA, erythropoiesis-stimulating agent; rHuEPO, recombinant human erythropoietin; Scr, screening.