Investor Presentaiton
WK 40
WK 28
WK 16
WK 4
DAY 1
SCR WK-8
No. of patients
Daprodustat
ESA
1477 1475 1449 1381 1323 1270 1225 1175 1125 1059 998 838 601 419 230
WK 64
WK 76
WK 52
1487 1485 1453 1403 1336 1274 1241 1191 1138 1092 1039 863 612 432 248
Co-primary Efficacy Endpoint: ASCEND-D
Mean Hb change from baseline to the evaluation period (Weeks 28-52) - ITT Population
Hb concentration (g/dL)
Daprodustat was noninferior to ESA for mean change in Hb from baseline
to the evaluation period (Weeks 28-52)
12
asceND D
✰ Daprodustat
ESA
11.5
11
10.5
10
9.5
9
DIALYSIS
EP
Prespecified NI margin:
-0.75 g/dL
Adjusted Mean Treatment
Difference (95% CI)*
0.18 (0.12, 0.24)
Noninferiority was achieved because the
lower limit of the 95% CI of the treatment
difference was greater than the prespecified
noninferiority margin of -0.75 g/dL
WK 148
WK 136
WK 112
WK 124
WK 100
WK 88
*Based on an ANCOVA model using observed and imputed data with terms for treatment, baseline hemoglobin, dialysis type and region. Error bars indicate 95% CI. Post-randomization values include on- and off-
treatment values. Visits on or before Day 1 include only pre-treatment values. Horizontal reference lines represent the Hb analysis range (10-11.5g/dL). The Hb target range for dose changes is 10-11g/dL. Vertical
dotted lines represent the EP.
Cl, confidence interval; EP, evaluation period; EOS, end of study; ESA, erythropoiesis-stimulating agent; FU, follow up; Hb, hemoglobin; ITT, intent-to-treat; NI noninferiority; SCR screening; Wk, week.
FU
EOS
862 639
839 628
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