drugset / Trial / NCT03799627

Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa

NCT03799627

Phase 2 Completed 175 enrolled Akebia Therapeutics
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.

Timeline

Start
2019-01-31
Primary completion
2020-06-05
Completion
2020-07-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Vadadustat Small molecule 300 mg Oral
Subject Vadadustat Small molecule 450 mg Oral
Subject Vadadustat Small molecule 600 mg Oral
Comparator epoetin alfa Protein / enzyme biologic