Efficacy, safety, and feasibility of roxadustat as part of a dialysis organization

Recent research demonstrated that roxadustat successfully achieved and maintained average hemoglobin levels of 10.0 g/dL or higher in patients who are on dialysis. The incorporation of oral roxadustat within dialysis organizations demonstrated a significant degree of adherence to dosing protocols, with no new safety issues identified. The results of this study were published in the journal Hemodialysis International.

Eligible individuals were treated with open-label roxadustat, administered three times weekly for a total of twenty-four weeks, with the possibility of extension of  ≤ 1 year. The initial dosing regimen depended on the dosage of erythropoiesis-stimulating agents (ESAs) at the time of screening for patients who had been on ESAs for six weeks or longer, while it was based on body weight for those who had been on ESAs for less than six weeks. This study's primary efficacy endpoints were the percentage of patients with a mean hemoglobin (Hb) level of at least 10.0 g/dL, averaged throughout the time period from weeks sixteen to twenty-four, as well as the mean change in hemoglobin from the baseline to the average observed from sixteen to twenty-four weeks. Additionally, treatment-emergent serious adverse events (TESAEs) and treatment-emergent adverse events (TEAEs) were evaluated.

Among the 281 patients screened, 203 underwent treatment, and 201 were incorporated into the complete analysis set. In total, 166 patients completed the twenty-four week treatment duration, with 126 proceeding into the extension period. The mean baseline hemoglobin level was 10.4 g/dL, and 82.6% of the participants underwent in-center hemodialysis. From weeks sixteen to twenty-four, a mean hemoglobin level of 10.0 g/dL or higher was achieved by 84.6% of the patients. The mean change in Hb from baseline during this timeframe was 0.5 (1.0) g/dL. Adherence to the dosing regimen was recorded at 94%. Additionally, 3.0% of patients received a red blood cell transfusion at up to week twenty-four. TESAEs and TEAEs were reported by 25.6% and 71.4% of patients, respectively. The most commonly reported TESAEs included COVID-19 (n = 5; 2.5%), as well as pneumonia, acute myocardial infarction, and sepsis (each n = 4; 2.0%).

Thus, it can be concluded that roxadustat was able to effectively reach and uphold mean hemoglobin levels of ≥10.0 g/dL in patients on dialysis. The successful incorporation of oral roxadustat into dialysis protocols has been shown, signifying compliance with the recommended dosing schedule.