BioCentury
ARTICLE | Clinical News

Roxadustat: Phase II data

November 9, 2015 8:00 AM UTC

An open-label Phase II trial in 60 incident dialysis CKD patients not receiving erythropoietin-stimulating agent (ESA) therapy showed that thrice-daily oral roxadustat for 12 weeks increased mean maximum hemoglobin, the primary endpoint, by 3.1 g/dL. Additionally, 96% of patients achieved a hemoglobin response, defined as a hemoglobin increase of >=1 g/dL, with a median time to hemoglobin response of 3 weeks. The mean maximum hemoglobin increase was 2.8 g/dL in patients who did not receive iron, 3.4 g/dL in patients who received oral iron and 3.5 g/dL in patients who received IV iron. Mean serum hepcidin levels decreased by 80% in patients who did not receive iron, 52% in patients who received oral iron and 41% of patients who received IV iron at week 4. Roxadustat was well tolerated. Data were published in The Journal of the American Society of Nephrology. ...