Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

Summary

This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.

Timeline

Start

2021-06-18

Primary completion

2023-01-06

Completion

2023-01-30

Outcome

Met primary endpoint

paper vadadustat was noninferior to MPG-EPO (n=152) for primary (least-squares mean treatment difference, -0.33; 95% CI, -0.53 to-0.13) PMID 39521398 ↗

release “In the FO2CUS study, each vadadustat dosing regimen (600mg, 900mg) and the combined vadadustat-treated group achieved the primary efficacy endpoint” akebia.com ↗

Publications

• Toka HR, Bernardo M, Burke SK, Luo W, Manllo-Karim R, Ullah I, Yang Z, Zhang Z, Tumlin J. Vadadustat Three Times Weekly in Patients With Anemia Due to Dialysis-Dependent CKD. Am J Kidney Dis. 2025 Apr;85(4):454-464.e1. doi: 10.1053/j.ajkd.2024.09.006. Epub 2024 Nov 7.
• Kooienga L, Burke S, Kathresal A, Luo W, Yang Z, Zhang Z, Zwiech R, Hernandez GT. Safety and Efficacy of Vadadustat Once Daily and Three Times Weekly in Patients With Dialysis-Dependent CKD With Anemia. Kidney360. 2024 Nov 1;5(11):1652-1661. doi: 10.34067/KID.0000000567. Epub 2024 Sep 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vadadustat	Small molecule	600 mg	Oral
Subject	Vadadustat	Small molecule	900 mg	Oral
Comparator	methoxy polyethylene glycol-epoetin beta	Protein / enzyme biologic	—	Intravenous

Indications