drugset / Trial / NCT06520826

Vafseo Outcomes In-Center Experience

NCT06520826

Phase 3 Active not recruiting 2200 enrolled USRC Kidney Research Akebia Therapeutics · collab
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

EvaluationDrugModalityDoseRoute
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