AstraZeneca Reports Results of Roxadustat in P-III OLYMPUS and ROCKIES Studies for Chronic Kidney Disease Patients with Anaemia
Shots:
- The P-III OLYMPUS study involve assessing of Roxadustat vs PBO in 2-781 patients with anaemia (Hb<10.0g/dL) in a ratio (1:1) in non-dialysis-dependent -CKD stages- resulted in improvement in Hb levels (1.75g/dL vs 0.40g/dL) and improvement in Hb levels in patients with elevated hsCRP levels > 5mg/L (1.73 g/dL vs 0.62g/dL)
- The P-III ROCKIES study involve assessing of Roxadustat vs epoetin alfa in 2-133 dialysis-dependent -CKD patients in a ratio (1:1) with anaemia either currently treated with an erythropoietin analogue (Hb<12g/dL) or not treated with an erythropoietin analogue (Hb<10g/dL)- resulted in improvement in Hb level (0.77g/dL vs 0.68g/dL) and improvement in Hb level in patients with elevated hsCRP levels > 5mg/L (0.80g/dL vs 0.59g/dL)
- Roxadustat is first-in-class- oral medicine and hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) being evaluated for the treatment of anaemia in chronic kidney disease with its anticipated regulatory submission in the US in Q4’19
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