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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

Target and mechanism

ModalitySmall molecule

Also known as Erythropoiesis-Stimulating Agent (ESA), Erythropoiesis Stimulating Agent

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment353

FDA Designations

No designations recorded

Clinical trial landscape

Erythropoiesis-Stimulating Agent · 1 trial · 1 indication

Phase 3 1
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 HemodialysisAnemia of Chronic Kidney Disease
ACTIVE NOT_RECRUITING353 Analytics
PHASE3ACTIVE NOT_RECRUITING
To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
Anemia of Chronic Kidney DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about Erythropoiesis-Stimulating Agent

What is Erythropoiesis-Stimulating Agent used for?

Erythropoiesis-Stimulating Agent (ESA) is used for the treatment of anemia of chronic kidney disease (CKD). It is being developed by Akebia Therapeutics, Inc. (AKBA) and is currently in Phase 3 clinical development. The drug is intended for patients with anemia associated with CKD, including those receiving in-center hemodialysis.

What does Erythropoiesis-Stimulating Agent target?

Erythropoiesis-Stimulating Agent (ESA) is a small molecule that stimulates erythropoiesis, the production of red blood cells. It is designed to treat anemia of chronic kidney disease by promoting the body's natural production of red blood cells, thereby increasing hemoglobin levels and reducing the need for blood transfusions.

Who makes Erythropoiesis-Stimulating Agent?

Erythropoiesis-Stimulating Agent (ESA) is being developed by Akebia Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AKBA. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with anemia of chronic kidney disease.

What phase is Erythropoiesis-Stimulating Agent in?

Erythropoiesis-Stimulating Agent (ESA) is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is evaluating the drug's efficacy compared to standard of care in patients with anemia of chronic kidney disease receiving hemodialysis.

What clinical trials is Erythropoiesis-Stimulating Agent in?

Erythropoiesis-Stimulating Agent (ESA) is being studied in a Phase 3 clinical trial with the identifier NCT06901505. This trial is evaluating the efficacy of three times weekly (TIW) vadadustat compared to standard of care ESA in patients with anemia of chronic kidney disease receiving in-center hemodialysis. The trial is active but not recruiting, with an enrollment of 353 participants in the United States.

Is Erythropoiesis-Stimulating Agent the same as vadadustat?

Erythropoiesis-Stimulating Agent (ESA) is also known as Erythropoiesis-Stimulating Agent (ESA) and Erythropoiesis Stimulating Agent. In the clinical trial NCT06901505, the drug being studied is referred to as vadadustat, which is the active agent being evaluated for the treatment of anemia of chronic kidney disease.