Investor Presentaiton
Co-primary Efficacy Endpoint: ASCEND-ND
Mean Hb change from baseline to the evaluation period (Weeks 28-52) ā ITT Population
Daprodustat was noninferior to darbepoetin alfa for mean change in Hb from baseline
to the evaluation period (Weeks 28-52)
12 ASCEND ND
ā° Daprodustat
Darbepoetin alfa
12.5
Hb concentration (g/dL)
NON-DIALYSIS
11.5
11-
10.5
10
9.5
9
8.5
EP
WK 148
WK 136
WK 124
WK 112
WK 100
WK 88
WK 76
WK 64
WK 52
WK 40
WK 28
WK 16
WK 4
DAY 1
SCR WK-8
FU
EOS
Prespecified NI margin:
-0.75 g/dL
Adjusted Mean Treatment
Difference (95% CI)*
0.08 (0.03, 0.13)
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
No. of patients
Daprodustat
Darbepoetin alfa
1936 1932 1866 1705 1511 1364 1254 1100 961 832 725 587 453 349 243
1935 1933 1867 1697 1506 1398 1243 1100 952 835 727 602 482 378 272
1276 1056
1278 1043
*Based on an ANCOVA model using observed and imputed data with terms for treatment, baseline hemoglobin, current ESA use 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.
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