drugset / Trial / NCT06520826
Vafseo Outcomes In-Center Experience
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.
Timeline
- Start
- 2024-11-20
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | — | — |
| Subject | Vadadustat | Small molecule | 300 mg | Oral |
| Comparator | epoetin alfa | Protein / enzyme biologic | — | — |
| Comparator | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | — | — |