Erythropoietin and iron supplements have been used for 30 years to treat anemia in patients with chronic kidney disease, but erythropoiesis-stimulating agents can only be safely used to increase hemoglobin levels to 11 g per deciliter. Roxadustat, a member of a new class of drugs called hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors, stimulates erythropoiesis and regulates iron metabolism. As reported in The New England Journal of Medicine, results from two Phase 3 randomized, clinical trials in China suggest that roxadustat may be beneficial for patients with chronic kidney disease. During the 26-week trials, 154 patients with chronic kidney disease not receiving dialysis and 305 patients undergoing long-term dialysis were randomized to receive either roxadustat or epoetin alfa (or a placebo for patients not receiving dialysis). Hemoglobin levels increased and hepcidin levels decreased in both groups of patients receiving roxadustat. Furthermore, roxadustat increased transferrin levels while maintaining serum iron levels and attenuated decreases in transferrin saturation levels. However, patients taking roxadustat were more likely to have hyperkalemia and upper respiratory infections. Allowing hemoglobin levels to be normalized, roxadustat may transform the treatment of chronic kidney disease. Ongoing clinical trials are monitoring roxadustat’s use over longer periods and in other populations.
References:
- Chen N, Hao C, Peng X, Lin H, et al. Roxadustat for anemia in patients with kidney disease not receiving dialysis. The New England Journal of Medicine 2019
- Chen N, Hao C, Liu BC, Lin H, et al. Roxadustat treatment for anemia in patients undergoing long-term dialysis. The New England Journal of Medicine 2019
- Kaplan J. Roxadustat and anemia of chronic kidney disease. The New England Journal of Medicine 2019