Table 3.
Participant characteristics (ITT population)
| rhEPO naïve |
rhEPO user |
Total |
||||
|---|---|---|---|---|---|---|
| Daprodustat | Control | Daprodustat | Control | Daprodustat | Control | |
| (n = 123) | (n = 43) | (n = 33) | (n = 36) | (n = 156) | (n = 79) | |
| Age, years, mean (SD) | 67.6 (12.21) | 64.3 (14.22) | 62.0 (14.06) | 66.7 (12.89) | 66.5 (12.78) | 65.4 (13.6) |
| Sex, female, n (%) | 75 (61) | 23 (53) | 17 (52) | 23 (64) | 92 (59) | 46 (58) |
| Weight (kg), mean (SD) | 73.2 (19.64) | 77.1 (16.03) | 77.1 (23.49) | 71.7 (18.60) | 74.1 (20.49) | 74.6 (17.35) |
| BMI (kg/m2), mean (SD) | 27.7 (6.9) | 28.4 (5.4) | 28.1 (7.1) | 27.3 (6.4) | 27.8 (6.9) | 27.9 (5.9) |
| Hemoglobin criteriaan (%) | ||||||
| Cohort 1 | 52 (42) | 18 (42) | 21 (64) | 17 (47) | 73 (47) | 35 (44) |
| Cohort 2 | 77 (58) | 25 (58) | 12 (36) | 19 (53) | 83 (53) | 44 (56) |
| Baseline hemoglobin level (g/dL), mean (SD)b | 9.9 (0.80) | 9.9 (0.73) | 10.2 (0.62) | 10.2 (0.57) | 10.0 (0.77) | 10.1 (0.67) |
| Type of rhEPO, n (%) | ||||||
| Epoetin SC | 0 | 0 | 14 (42) | 5 (14) | 14 (42) | 5 (14) |
| Darbepoetin | 0 | 0 | 19 (58) | 30 (86) | 19 (58) | 30 (86) |
| Geographical region, n (%) | ||||||
| Japan | 17 (14) | 6 (14) | 9 (27) | 9 (25) | 26 (17) | 15 (19) |
| North America | 35 (28) | 6 (14) | 6 (18) | 7 (19) | 41 (26) | 13 (16) |
| Russia | 15 (12) | 10 (23) | 9 (27) | 2 (6) | 24 (15) | 12 (15) |
| Rest of world | 56 (46) | 21 (49) | 9 (27) | 18 (50) | 65 (42) | 39 (49) |
| Stage of CKD, n (%) | ||||||
| 2 | 0 | 0 | 0 | 1 (3) | 0 | 1 (1) |
| 3a | 4 (3) | 1 (2) | 1 (3) | 1 (3) | 5 (3) | 2 (3) |
| 3b | 23 (19) | 6 (14) | 3 (9) | 3 (8) | 26 (17) | 9 (11) |
| 4 | 58 (47) | 17 (40) | 17 (52) | 15 (42) | 75 (48) | 32 (41) |
| 5 | 38 (31) | 19 (44) | 12 (36) | 16 (44) | 50 (32) | 35 (44) |
| Baseline eGFR (mL/min/1.73 m2), mean (SD) | 21.3 (10.69) | 19.4 (10.9) | 17.9 (9.17) | 18.8 (11.97) | 20.6 (10. 45) | 19.2 (11.3) |
| Cardiovascular risk factors, n (%)c | n = 134 | n = 45 | n = 36 | n = 35 | n = 170 | n = 80 |
| Any | 29 (22) | 12 (27) | 9 (25) | 6 (17) | 38 (22) | 18 (23) |
| Angina pectoris | 7 (5) | 5 (11) | 0 | 3 (9) | 7 (4) | 8 (10) |
| Hyperlipidemia | 4 (3) | 2 (4) | 1 (3) | 0 | 5 (3) | 2 (3) |
| Hypertension | 2 (1) | 0 | 1 (3) | 0 | 3 (2) | 0 |
| Diabetes | 0 | 0 | 2 (6) | 0 | 2 (1) | 0 |
BMI, body mass index; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; rhEPO, recombinant human erythropoietin; SC, subcutaneous; SD, standard deviation.
a
Hemoglobin entry criteria for rhEPO-naïve participants were 8–10 g/dL in Cohort 1 and 8–11 g/dL in Cohort 2. Criteria in rhEPO users were 9.0–10.5 g/dL in Cohort 1 and 9.0–11.5 g/dL in Cohort 2.
b
Baseline hemoglobin levels for Cohort 1 and Cohort 2 combined.
c
Safety population.