Roxadustat Versus Epoetin Alfa for Treating Anemia in Patients with Chronic Kidney Disease on Dialysis: Results from the Randomized Phase 3 ROCKIES Study
In more than 2,100 dialysis patients, the oral HIF-PHI roxadustat raised hemoglobin at least as well as injectable epoetin alfa, with a comparable rate of adverse events — offering a pill-based alternative for managing anemia on dialysis.
Background
Erythropoiesis-stimulating agents are standard for anemia in dialysis-dependent CKD but carry cardiovascular safety concerns, motivating alternatives such as oral HIF prolyl hydroxylase inhibitors.
Study design
ROCKIES was an open-label phase 3 trial randomizing 2,133 dialysis patients with anemia 1:1 to thrice-weekly oral roxadustat or parenteral epoetin alfa; the primary endpoint was mean hemoglobin change from baseline averaged over weeks 28-52, tested for non-inferiority.
Key findings
Mean hemoglobin change was 0.77 g/dL with roxadustat versus 0.68 g/dL with epoetin alfa (non-inferior; least-squares mean difference 0.09 g/dL). Rates of any adverse event (85.0% vs 84.5%) and serious adverse events (57.6% vs 57.5%) were comparable between groups.
Clinical implications
Roxadustat offers an oral alternative to injectable ESAs for anemia in dialysis-dependent CKD; this trial assessed hemoglobin and adverse events rather than long-term cardiovascular endpoints, so class-level cardiovascular and thromboembolic safety remains to be defined by dedicated outcome analyses.
Category
Research
Source
Journal of the American Society of Nephrology
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