The investigational drug enarodustat can correct and maintain hemoglobin (Hb) levels in patients with chronic kidney disease patients (CKD) who have anemia, new study findings suggest.
Tadao Akizawa, MD, of Showa University School of Medicine, and colleagues tested enarodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in Japanese patients with non-dialysis CKD in a phase 2b trial. The investigators defined 2 groups: A correction group of 94 patients who had not received erythropoiesis-stimulating agents (ESAs) in the previous 12 weeks and a conversion group of 103 patients who had received stable doses of ESA. Investigators randomly assigned patients to receive once-daily enarodustat in doses of 2, 4, or 6 mg, or to placebo for 6 weeks in the anemia correction group and up to 30 weeks for patients in the conversion group, who had dose adjustments.
By the end of the study period, 70% of both groups maintained Hb within a target range of 10 to 12 g/dL with enarodustat therapy, according to results published in the American Journal of Nephrology. In the correction group, Hb levels increased along with enarodustat dose. Average doses were 3.58 and 3.74 mg/day in the correction group and the conversion group, respectively.
Commonly reported adverse events included nasopharyngitis, hypertension (due to underlying causes), hyperkalemia, and constipation. Most serious adverse events were not considered drug related, but 1 instance of bone cancer and deep vein thrombosis could not be ruled out.
“Effects on iron-related parameters suggest that enarodustat improves iron utilization,” Dr Akizawa and the team explained. The drug is currently being examined in phase 3 studies.
Akizawa T, Nangaku M, Yamaguchi T, et al. A Placebo-controlled, randomized trial of enarodustat in patients with chronic kidney disease followed by long-term trial. Am J Nephrol 2019;49:165–174. DOI: 10.1159/000496929