Clinical Trials/NCT03054350

NCT03054350

Completed

Phase 2

Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Akebia Therapeutics0 sites60 target enrollmentDecember 2016

ConditionsAnemia Dialysis Dependent Chronic Kidney Disease

InterventionsVadadustat Placebo

DrugsVadadustat Placebo

Overview

Phase: Phase 2
Intervention: Vadadustat
Conditions: Anemia
Sponsor: Akebia Therapeutics
Enrollment: 60
Primary Endpoint: Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

January 24, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Akebia Therapeutics

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Vadadustat, Dose 1

Daily oral dose

Intervention: Vadadustat

Vadadustat, Dose 2

Daily oral dose

Intervention: Vadadustat

Vadadustat, Dose 3

Daily oral dose

Intervention: Vadadustat

Placebo

Daily oral dose

Intervention: Placebo

Outcomes

Primary Outcomes

Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period

Time Frame: Pre-treatment; Week 6

The pre-treatment average value for Hb was defined as the average of 3 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 6 value minus the Pre-treatment value.

Secondary Outcomes

Mean Hb Levels at the End of the Primary Efficacy Period(up to Week 6)
Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period(up to Week 16)
Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period(Pre-treatment; Week 16)
Number of Participants Who Achieved the Target Hb Level of 10.0 to 12.0 g/dL at the End of the Dose Adjustment and Maintenance Period(up to Week 16)
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
Mean Change in Transferrin Saturation (TSAT) From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
Mean Change in TSAT From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
Number of Participants Who Required Rescue With Erythropoiesis-Stimulating Agents (ESAs) From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16(from Baseline up to Week 16)
Mean Change in Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
Number of Participants Who Required Rescue With RBC Transfusion From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
Number of Participants Who Required Rescue With ESAs From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4(Week 4, pre-dose)
Mean Change in Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period(Baseline; Week 6)
Mean Change in Iron and TIBC From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Dose Adjustment and Maintenance Period(Baseline; Week 16)
Number of the Participants With the Indicated Number of Dose Adjustments From Baseline to the End of the Dose Adjustment and Maintenance Period(up to Week 16)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) in the Primary Efficacy Period(up to Week 6)
Number of Participants With TEAEs and Treatment-emergent SAEs in the Dose Adjustment and Maintenance Period(up to Week 16)