Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Study Overview
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Brief Summary
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This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Official Title
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Phase 3, Randomized, Open Label, Active Controlled Study Evaluating the Efficacy and Safety of Three Times Per Week (TIW) Oral Dosing of Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILO2GY)

Conditions
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Anemia, Dialysis-Dependent Chronic Kidney Disease

Intervention / Treatment
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* Drug: Vadadustat
* Drug: Darbepoetin 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 in-center hemodialysis (3 times per week) for end-stage kidney disease Currently maintained on ESA therapy Mean screening Hb between 8.0 and 11.0 g/dL (inclusive) 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>Oral tablet | Drug: Vadadustat<br>* Oral tablet<br>* Other names: AKB-6548;|
| Active Comparator: Darbepoetin alfa<br>subcutaneous or intravenous | Drug: Darbepoetin alfa<br>* subcutaneous or intravenous<br>* Other names: Aranesp;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Hb between baseline and the primary evaluation period | Mean change in hemoglobin will be evaluated | Baseline visit, Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Hb between baseline and the secondary evaluation period | Mean change in hemoglobin will be evaluated | Baseline visit, Week 52 | 
| Proportion of subjects with mean Hb within the target range during the primary evaluation period | Hemoglobin values within the target range will be evaluated | Baseline visit, Week 36 | 
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated | 52 weeks | 

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