Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

Study Overview
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Brief Summary
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This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease (DD-CKD) who are hyporesponsive to erythropoiesis stimulating agents (ESAs.)

Official Title
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Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

Conditions
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Anemia, Dialysis-Dependent Chronic Kidney Disease

Intervention / Treatment
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* Drug: vadadustat
* Drug: epoetin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects ≥18 years of age Receiving chronic maintenance hemodialysis for end-stage kidney disease Currently receiving epoetin alfa for anemia Hb between 8.5 and 10.0 g/dL during screening Exclusion Criteria: Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia Red blood cell transfusion within 4 weeks prior to or during screening Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vadadustat<br>Vadadustat daily oral dose, adjustable based on Hb level | Drug: vadadustat<br>* vadadustat<br>* Other names: AKB-6548;|
| Active Comparator: epoetin alfa<br>Epoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study | Drug: epoetin alfa<br>* epoetin alfa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period |  | Baseline; up to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period |  | Baseline; up to 20 weeks | 
| Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period |  | Baseline; up to 20 weeks | 
| Number of Participants Receiving Epoetin Alfa Rescue |  | up to 20 weeks | 
| Number of Participants Receiving Red Blood Cell Transfusion |  | up to 20 weeks | 
| Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor |  | up to 20 weeks | 
| Mean Weekly Dose of Intravenous Elemental Iron Administered |  | up to 20 weeks | 
| Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%) |  | up to 20 weeks | 
| Number of Participants Utilizing Resources |  | up to 20 weeks | 
| Number of Participants With Treatment-emergent Adverse Events | Treatment-emergent adverse events were collected in all participants enrolled in the study. | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, hyporesponder, anemia, kidney, dialysis-dependent chronic kidney disease, DD-CKD, renal, vadadustat, AKB-6548, hypoxia-inducible factor, HIF, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI, hyporesponsive, epoetin alfa, hemoglobin, erythropoiesis stimulating agent, ESA