Study Enrollment
Iron*
Hb (g/dL)*
CKD Status*
ESA Treatment*
eGFR ≤60 mL/min/1.73 m2
Ferritin ≥100 ng/mL
Transferrin
saturation ≥20%
Maintained on ESA‡
Without ESA use†
ESA
TREATED
ESA
UNTREATED
*At screening.
†Patients with ESA use within 8 weeks prior
to
randomization were excluded.
‡A dose received within 6 weeks prior to or during screening.
Randomized, open-label, active-controlled (vadadustat vs. darbepoetin alfa), non-inferiority, cardiovascular outcomes studies
ESA UNTREATED
ESA TREATED
*Until end of treatment.
Vadadustat 300 mg QD starting dose (oral
tablet)
Flexible titration (150-600 mg/d) based on hemoglobin level
Hemoglobin targets: US, 10–11 g/dL; ex-US, 10–12 g/dL
Darbepoetin alfa
(subcutaneous)
Dosed
based on approved local label for adults with NDD-CKD
ESA UNTREATED
ESA TREATED
Safety
Time to major adverse
cardiovascular events
(MACE)*
Efficacy
Mean change in hemoglobin
(baseline to
weeks 24-36)
Safety
Time to expanded MACE†
Efficacy
Change in hemoglobin
(baseline to weeks
40-52)
Proportion of patients with
hemoglobin
within target range
(baseline to weeks 24-36)
*Defined
as
all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke (event driven, ≥1
year).
†MACE plus
hospitalization for heart failure or thromboembolic event, excluding vascular access failure.
