drugset / Trial / NCT04707768
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
RandomizedParallel-groupOpen-labelTreatment
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
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 |