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

• Status: Completed
• Trial end date: 2018-01-24
• Target enrollment: 0
• Participant gender: All

Summary

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 Dialysis-dependent Chronic Kidney Disease (DD-CKD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akebia Therapeutics

Criteria

Inclusion Criteria:

• Male and female Japanese participants ≥20 years of age

• Receiving chronic maintenance hemodialysis for end-stage kidney disease

• Hemoglobin (Hb) <10.0 grams per deciliter (g/dL)

Exclusion Criteria:

• Anemia due to a cause other than chronic kidney disease (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