drugset / Trial / NCT03799627
Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |