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Erythropoiesis-Stimulating Agent

Phase 3

Anemia of Chronic Kidney Disease | Small molecule | Hematology |Akebia Therapeutics, Inc.|Last Updated: Feb 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment353
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06901505To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center HemodialysisPHASE3 ACTIVE NOT_RECRUITING 353Jul 24, 2025Aug 1, 2026Feb 23, 202618 United States
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Study Endpoints
Primary Endpoints
Change in hemoglobin (Hb)
Baseline and the mean of Week 20 to 24
Secondary Endpoints
Number of participants reporting treatment-emergent serious adverse events (TESAEs)
Up to 29 Weeks
Proportion of participants with mean Hb levels within target range
Week 16 to Week 24
Proportion of participants receiving RBC transfusions
Up to 29 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VadadustatEXPERIMENTALStudy drug will be administered three times a week.
Erythropoiesis-Stimulating Agent (ESA)ACTIVE_COMPARATORDose adjustments will be determined by hemoglobin (Hb) change and current dose of ESA, per ESA dosing protocol
Interventions
NameTypeDescription
Erythropoiesis-Stimulating Agent (ESA)DRUGAdministered by intra-venous (IV) infusion.
VadadustatDRUG300mg, oral tablets
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Adult participants ≥18 years of age. * Receiving outpatient in-center hemodialysis for ESKD at least three times a week. * Currently prescribed or meets criteria for ESA based on approved facility policy. * Hb \> 8 grams per deciliter (g/dl). * Serum ferritin ≥100 nanograms pe...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06901505primaryCompletionDate: changed
LOWMay 24, 2026NCT06901505studyFirstPostDate: changed