NCT03799627

Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa

Phase 2, Randomized, Open-Label, Active-Controlled, Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects Converting From Epoetin Alfa (FO2RWARD-2)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.

Detailed description

This is a Phase 2, randomized, open-label study to evaluate efficacy and safety of oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy. The study will be conducted in two parts running in parallel: Part 1, Main Study in a hemodialysis population on maintenance treatment with Epoetin Alfa; Part 2 is in a hemodialysis population that are erythropoiesis-stimulating agent (ESA) hyporesponders on maintenance treatment with Epoetin Alfa. For all participants (Main and ESA hyporesponder parallel study), the study will include a Screening Period, a Treatment Period, and a Safety Follow-Up Period. PK and PD sampling will be done throughout the study. The aim is to achieve and maintain hemoglobin (Hb) levels within the target range of 10.0 to 11.0 grams per deciliter (g/dL), inclusive, while targeting the middle of the range and minimizing excursions outside the target range.

Conditions

• Anemia
• Dialysis-dependent Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Vadadustat	Vadadustat Tablets 150 mg
DRUG	Epoetin Alfa	Epoetin Alfa
DRUG	Vadadustat TIW	Oral Vadadustat

Timeline

• Start date: 2019-01-31
• Primary completion: 2020-06-05
• Completion: 2020-07-15
• First posted: 2019-01-10
• Last updated: 2022-09-29
• Results posted: 2022-09-29

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated drug study