Roxadustat led to a numerically greater mean change in haemoglobin level from baseline to weeks 23 through 27 (0.7g per deciliter) than epoetin alfa (0.5g per deciliter) and was statistically noninferior (difference, 0.2g per deciliter; 95% CI, −0.02 to 0.5).
This is one of two phase 3 trials carried out in China. In the other study, roxadustat was superior to placebo in increasing haemoglobin levels in patients with anaemia.
An editorial notes that although the present trials indicate roxadustat effectively treated anaemia while reducing hepcidin levels and maintaining lower levels of erythropoietin, adverse events may yet appear when larger, longer trials are completed. Further data are awaited from ongoing trials and from additional studies re-examining the risks and benefits of normalisation of the haemoglobin level in patients with anaemia of chronic kidney disease and carefully monitoring for as yet unappreciated problems with HIF prolyl hydroxylase inhibitors. It suggests that if HIF prolyl hydroxylase inhibitors fulfill their promise and facilitate normalisation of haemoglobin levels in this population, and reduce cardiovascular morbidity related to anaemia without the increased risks that have been seen in trials of erythropoietin-stimulating agents, there might ultimately be a revolution in the treatment of anaemia of chronic kidney disease.