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Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the initiation of a post-marketing study to identify additional potential benefits of Vafseo® (vadadustat). The VOCAL trial, conducted within DaVita clinics, aims to generate data to evaluate the efficacy and safety of three times per week (TIW) dosing of vadadustat compared to standard of care erythropoiesis-stimulating agents (ESA) in patients with anemia of CKD receiving in-center hemodialysis.
The VOCAL trial is expected to enroll approximately 350 patients across 18 DaVita hemodialysis clinics. This open-label trial will employ 1:1 randomization. Patients will participate in the study for up to 33 weeks including screening, treatment and safety follow-up. The primary endpoint of the study is change in hemoglobin, and secondary endpoints include number of patients reporting treatment-emergent serious adverse events, proportion of patients within target hemoglobin range and proportion of patients receiving RBC transfusions, in each case, compared to ESA treatment.
The VOCAL trial will also include a sub-study of approximately 28 patients from three clinics who will have blood samples collected and analyzed over the course of a 6-month treatment period. One major factor contributing to the anemia of CKD patients is reduced red blood cell (RBC) quality. Working in consultation with Vitalant Research Institute, the intent of the sub-study is to better understand the impact of Vafseo on RBC phenotypes (e.g. deformability, resistance to oxidative stress, metabolomics) compared to ESA treatment.
Vafseo was approved by the U.S. Food and Drug Administration in March 2024 for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months, and the product became available in the U.S. in January 2025.
Posted In: AKBA
