Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)

Akebia Therapeutics

Status and phase: Completed; Phase 2

Conditions: Non-dialysis Dependent Chronic Kidney Disease; Anemia

Treatments: Drug: Placebo; Drug: Vadadustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03054337

AKB-6548-CI-0021

Details and patient eligibility

About

This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD).

Enrollment: 51 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female Japanese participants ≥20 years of age
• Diagnosis of chronic kidney disease (CKD) based on an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m^2)
• Hemoglobin (Hb) ≤10.5 grams per deciliter (g/dL)
• Not currently being treated with dialysis and not expected to start dialysis within 3 months of 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
• Intravenous iron within 4 weeks prior to or during screening
• Any use of erythropoiesis-stimulating agents within 6 weeks prior to or during screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 4 patient groups, including a placebo group

Vadadustat, Dose 1

Experimental group

Description:

Daily oral dose

Treatment:

Drug: Vadadustat

Vadadustat, Dose 2

Experimental group

Description:

Daily oral dose

Treatment:

Drug: Vadadustat

Vadadustat, Dose 3

Experimental group

Description:

Daily oral dose

Treatment:

Drug: Vadadustat

Placebo

Placebo Comparator group

Description:

Daily oral dose

Treatment:

Drug: Placebo