This European, phase 3, randomized, open-label, active-controlled study investigated the efficacy and safety of roxadustat in patients with end-stage kidney disease on stable (prevalent) dialysis for at least 4 months.

Patients were randomized to (a) switch from their previous erythropoiesis-stimulating agent (ESA) treatment (epoetin or darbepoetin alfa) to oral roxadustat therapy three times/week, or (b) to continue with their previous ESA.

The least squares means (95% CI) of the treatment difference (roxadustat − ESA) for hemoglobin change from baseline to weeks 28–36 (without rescue therapy) and from baseline to weeks 28–52 (regardless of rescue therapy) were 0.235 (0.132, 0.339) g/dL and 0.171 (0.082, 0.261) g/dL, respectively, demonstrating non-inferiority of roxadustat to ESA (non-inferiority margin of − 0.75 g/dL).

Roxadustat was also superior to ESA in decreasing LDL cholesterol from baseline to the average of weeks 12–28.

The most common treatment-emergent adverse events in both treatment groups were hypertension, arteriovenous fistula thrombosis, headache, and diarrhea.