drugset / Trial / NCT07565701
Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis
NaSingle-groupOpen-labelTreatment
Summary
The goal of this study is to assess if patients can be retained on long-term vadadustat therapy (and thus potentially benefit from the favorable safety profile) by incorporating a phased transition from Epogen to three times per week vadadustat (TIW-V), reducing the likelihood of GI intolerance through use of a lower vadadustat starting dose, and also reducing or eliminating the initial reduction in hemoglobin through the maintenance of low dose Epogen until target hemoglobin stability is achieved on a tolerable dose of TIW-V.
Timeline
- Start
- 2026-04
- Primary completion
- 2027-04
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epoetin alga | Unknown | — | — |
| Subject | Vadadustat | Small molecule | 300 mg | Oral |