Clinical Parameters in Patients with CKD-related Anemia Treated with Roxadustat

Tadao Akizawa, MD, and colleagues reported results of a post hoc analysis of data from a Japanese open-label, partially randomized, phase 3 study in patients with non-dialysis dependent chronic kidney disease (NDD-CKD). The study was designed to examine disease state-related parameters among patients with and without diabetes mellitus who received roxadustat. Results were reported online in Clinical and Experimental Nephrology [].

Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase for the treatment of anemia of CKD. In the 1517-CL-0310 study (NCT02988973), roxadustat was noninferior to darbepoetin alfa for change in average hemoglobin levels at weeks 18 to 24 from baseline. The post hoc analysis included patients enrolled in the study who received roxadustat.

The researchers descriptively summarized parameters by visit through week 52. The parameters were: hematologic (hemoglobin, reticulocyte/erythrocyte ratio, mean corpuscular volume [MCV] and mean corpuscular hemoglobin [MCH]); iron-related (ferritin, total iron-binding capacity, transferrin, ceruloplasmin, and hepcidin); metabolic (hemoglobin A1c [HbA1c], glycated albumin, total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol); and renal (estimated glomerular filtration rate).

Of the 201 patients in the analysis, 552.% (n=105) were in the diabetes subgroup and 47.8% (n=96) were in the no diabetes subgroup. There were no clinically meaningful differences through week 52 between the two subgroups for most of the hematologic, iron-related, metabolic, or renal parameters. In patients in the diabetes subgroup, MCV and MCH remained lower and HbA1c and glycated albumin remained higher through week 52.

In both subgroups, patients experienced a similar benefit from roxadustat in maintaining hemoglobin levels in the target range of 10 to 12 g/dL.

In summary, the researchers said, “Roxadustat maintained hemoglobin levels in the target range with similar clinical parameters irrespective of diabetes mellitus presence at baseline.”