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Clinical Data
The Phase 2 study in Japan of CKD patients not on dialysis was a multi-center, randomized, parallel-group, placebo-controlled, double-blind study over 24 weeks. The subjects, 107 CKD patients not yet receiving dialysis, were randomized to one of three roxadustat treatment arms (50 mg, 70 mg, 100 mg) or to a placebo arm, with roxadustat orally administered three times weekly (TIW) for the first six weeks of the study to evaluate dose response of efficacy and safety. This was followed by dose titration every four weeks until hemoglobin response was achieved, at which point hemoglobin was maintained with patients randomized to one of two dosing regimens (continuation of TIW dosing or a change to weekly (QW) dosing).Results showed achievement in the full analysis set of dose response in the three roxadustat treatment arms, with a mean rate of Hb increase of 0.200, 0.453, and 0.570 g/dL per week (50 mg, 70 mg, 100 mg, respectively), as measured over the first six weeks of the study, compared to a mean Hb decrease of 0.052 g/dL per week in subjects receiving placebo. Of note, 93.8% of roxadustat-treated subjects achieved hemoglobin correction as measured by hemoglobin response defined as Hb more than or equal to 10 g/dL and Hb increase of at least 1 g/dL from baseline. In the placebo arm, hemoglobin response was achieved in 14.8% of the subjects. Roxadustat was well tolerated, with no deaths and no major adverse cardiovascular events reported for roxadustat-treated patients.The Phase 2 study in Japan in 130 CKD patients receiving dialysis was a multi-center, randomized, darbepoetin-controlled, double blind (roxadustat arms), open-label (darbepoetin) study over 24 weeks in CKD patients on chronic stable dialysis. The subjects who had discontinued previous standard-of-care therapy (erythropoiesis-stimulating agents) to reach Hb levels of < 9.5 g/dL were randomized to one of three roxadustat arms (administered orally TIW at a fixed dose) or to the darbepoetin arm (darbepoetin administered intravenously QW) over the first six weeks of the study to evaluate dose response of efficacy and safety, followed by dose titration to the desired Hb level every four weeks.During weeks 18 to 24, average Hb levels achieved (a secondary endpoint) in the full analysis set were 10.31 g/dL (1.33 g/dL Hb increase), 10.20 g/dL (1.37 g/dL Hb increase), and 10.53 g/dL (1.57 g/dL Hb increase), respectively, in the roxadustat treatment arms, compared to 10.25 g/dL (1.42 g/dL Hb increase) in the darbepoetin arm. Roxadustat was well tolerated in this study, with one death reported in a subject who suffered from bacterial pneumonia and thromboembolism, whose death was deemed unrelated to roxadustat; no deaths were reported in the other treatment arms.

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