Randomized, open-label, active-controlled non-inferiority, cardiovascular outcomes studies
Over 7000 patients enrolled to assess cardiovascular safety and efficacy endpoints across multiple patient types
CKD Status*
Hb (g/dL)*
≥18 Years of Age
Study Enrollment
eGFR ≤60 mL/min/1.73 m2
ESA
UNTREATED
(Correction)
ESA
TREATED
(Conversion)
Study Enrollment
Initiated dialysis within
16 weeks
Received maintenance dialysis for at least 12 weeks
INCIDENT
DIALYSIS
(Correction/Conversion)
PREVALENT
DIALYSIS
(Conversion)
≥18 Years of Age
CKD Status*
Hb (g/dL)*
*At screening.
Randomized, open-label, active-controlled vadadustat vs. darbepoetin alfa, non-inferiority, cardiovascular outcomes studies
ESA
UNTREATED
(Correction)
ESA
TREATED
(Conversion)
INCIDENT
DIALYSIS
(Correction/Conversion)
PREVALENT
DIALYSIS
(Conversion)
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 or IV
injection
Dosed based
on approved local label for adults with CKD
The cardiovascular safety and efficacy endpoints are the same across the studies
ESA
UNTREATED
(Correction)
ESA
TREATED
(Conversion)
INCIDENT
DIALYSIS
(Correction/Conversion)
PREVALENT
DIALYSIS
(Conversion)
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.
MED-VD-US-0041 (v2.0) 03/24
