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Vadadustat
Global Phase 3 Program

 

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Clinical Program Overview:

Global Phase 3 Program

Anemia Due to CKD (DD-CKD)

Anemia Due to CKD (NDD-CKD)

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Randomized, open-label, active-controlled non-inferiority, cardiovascular outcomes studies

Completed
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PopulationDesignEndpoints

Population

Over 7000 patients enrolled to assess cardiovascular safety and efficacy endpoints across multiple patient types

CKD Status Green Icon

CKD Status*

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Hb (g/dL)*

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≥18 Years of Age

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Study Enrollment

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eGFR ≤60 mL/min/1.73 m2

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N=1725

N=1751

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ESA
UNTREATED

(Correction)

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ESA
TREATED

(Conversion)

Anemia Due to CKD (NDD-CKD)

N=3554

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Study Enrollment

N=369

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Initiated dialysis within
16 weeks

Received maintenance dialysis for at least 12 weeks

Incident Dialysis HB Scale Level IconPrevalent Dialysis HB Scale Level Icon
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INCIDENT
DIALYSIS

(Correction/Conversion)

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PREVALENT
DIALYSIS

(Conversion)

Anemia Due to CKD (DD-CKD)

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≥18 Years of Age

CKD Status Icon

CKD Status*

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Hb (g/dL)*

*At screening.

Design

Randomized, open-label, active-controlled vadadustat vs. darbepoetin alfa, non-inferiority, cardiovascular outcomes studies

Anemia Due to CKD (NDD-CKD)

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ESA UNTREATED
(Correction)

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ESA TREATED
(Conversion)

+

Anemia Due to CKD (DD-CKD)

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INCIDENT DIALYSIS
(Correction/Conversion)

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PREVALENT DIALYSIS
(Conversion)

Randomized
1:1
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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

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Darbepoetin alfa
Subcutaneous or IV injection
Dosed based on approved local label for adults with CKD

Endpoints

The cardiovascular safety and efficacy endpoints are the same across the studies

Anemia Due to CKD (NDD-CKD)

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ESA UNTREATED
(Correction)

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ESA TREATED
(Conversion)

+

Anemia Due to CKD (DD-CKD)

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INCIDENT DIALYSIS
(Correction/Conversion)

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PREVALENT DIALYSIS
(Conversion)

Primary Endpoints

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Safety

  • Time to major adverse cardiovascular events (MACE)*

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Efficacy

  • Mean change in hemoglobin
    (baseline to weeks 24-36)

Key Secondary Endpoints

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Safety

  • Time to expanded MACE†

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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.

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MED-VD-US-0041 (v2.0) 03/24