Investor Presentaiton
ASCEND-D and -ND: Trial Design
Event-driven, open-label, randomized, active-controlled, parallel-group, multicenter, Phase 3 trials
ASCEND-D and ASCEND-ND accepted for publication
Co-primary Endpoints
Open-label* 1:1
randomization
4-week
screening
4-week
placebo run-in
R
Daprodustat, oral, daily
Hb treatment target:
10.0-11.0 g/dL
Iron management protocol
applied to both arms
ESA+ (D)
Darbepoetin alfa, SC (ND)
ASCEND-ND: Key Entry Criteria
Mean change in Hb from
baseline to the average
during the primary
evaluation period
(Week 28 through Week 52)
Time to first MACE+
(target 664 adjudicated
first events)
ASCEND-D: Key Entry Criteria
≥18 years
of age
Randomization Hb criteria:
Hb 8.0-11.5 g/dL
ESA users
Dialysis (HD/PD) >90 days prior to screening
Iron replete: Ferritin >100 ng/mL; TSAT >20%
•
≥18 years of age
CKD Stage 3-5
Randomization Hb criteria:
-
Hb 8.0-10.0 g/dL, if not using ESAs
-
Hb 8.0-11.0 g/dL, if using ESAs
Not on dialysis and no plans to start within 90 days
Iron replete: Ferritin >100 ng/mL; TSAT >20%
*The sponsor, steering committee and endpoint adjudication committee remained blind to aggregate treatment assignment throughout the trial.
+Epoetin alfa (IV; HD patients) or darbepoetin alfa (SC; PD patients). #MACE: composite of all-cause mortality, a non-fatal myocardial infarction, or a non-fatal stroke.
CKD, chronic kidney disease; ESA, erythropoiesis-stimulating agent; Hb, hemoglobin; HD, hemodialysis; IV, intravenous; MACE, major adverse cardiovascular event; PD, peritoneal
dialysis; R, randomization; SC, subcutaneous; TSAT, transferrin saturation.
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