Table 4.
Pharmacokinetic values for C.E.R.A. after subcutaneous injection. Results are given as mean ± SD, apart from Tmax and CL/F, which are given as median values.
| C.E.R.A. dose group, μg/kg (n) | Cmax (ng/mL) | Tmax (h) | AUC (ng • h/mL)* | t1/2 (h) | CL/F (mL/h/kg) |
| QW | |||||
| 0.7 (14) | 6.7 ± 2.5 | 71 | 931 ± 358 | 171 ± 69† | 25.3 |
| 1.4 (16) | 10.6 ± 4.1 | 74 | 1355 ± 548‡ | NC** | 25.1 |
| 2.1 (15) | 20.2 ± 8.7 | 70 | 2709 ± 1193 | 212 ± 200† | 23.4 |
| Q3W | |||||
| 2.1 (18) | 8.2 ± 3.8 | 120 | 2750 ± 1318 | 157 ± 38† | 34.7 |
| 4.2 (18) | 16.6 ± 9.5 | 82 | 4651 ± 2569‡ | 174 ± 44† | 42.8 |
| 6.3 (17) | 20.9 ± 12.5 | 120 | 6547 ± 3957‡ | 186 ± 78† | 49.4 |
AUC: area under the serum concentration-time curve.
C.E.R.A.: Continuous Erythropoietin Receptor Activator.
CL: clearance.
Cmax: maximum serum concentration.
F: bioavailability.
QW: once weekly.
Q3W: once every 3 weeks.
SD: standard deviation.
Tmax: time to Cmax.
t1/2: terminal half-life.
*AUC22–29 days for QW group and AUC22–43 days for Q3W group.
**NC, not calculated (n = 2).
†n = 4 and 3 in 0.7 and 2.1 QW groups, respectively, and n = 11, 15, 14 in 2.1, 4.2, and 6.3 Q3W groups, respectively.
‡n = 15, 16, and 14 for 1.4 QW. 4.2 Q3W, and 6.3 Q3W groups, respectively.