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

NCT07565701

Phase 3 Not yet recruiting 100 enrolled Geoff Block Akebia Therapeutics · collab
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

EvaluationDrugModalityDoseRoute
Subject Epoetin alga Unknown
Subject Vadadustat Small molecule 300 mg Oral