NCT04313153

Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

Phase 3b, Randomized, Open-label, Active-controlled Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 319 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will be conducted to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants after conversion from current erythropoiesis-stimulating agent (ESA) therapy.

Detailed description

This study consists of three periods: 1. Screening Period 2. Conversion and Maintenance Treatment Period 3. Safety Follow-up Period Individual participants will participate in total trial duration of approximately 64 weeks.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Vadadustat	oral tablets
DRUG	Darbepoetin alfa	intravenous or subcutaneous solution

Timeline

• Start date: 2020-05-27
• Primary completion: 2021-11-26
• Completion: 2022-06-22
• First posted: 2020-03-18
• Last updated: 2025-05-22
• Results posted: 2025-05-22

Locations

59 sites across 6 countries: United States, Czechia, Hungary, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study