Astellas Reports Results of Roxadustat in P-III DOLOMITES Study to Treat Anemia in Non-Dialysis Dependent Adult Patients with Chronic Kidney Disease
Shots:
- The P-III study involves assessing of Roxadustat (N=323) vs darbepoetin alfa (N=293) evaluating its safety and efficacy in (N=616) adult anemia patients with stage 3–5 chronic kidney disease (CKD)
- The study meet its 1EPs & 2EPs also demonstrated superiority- showing correction of hemoglobin levels during the first 24 wks. (89.5% vs 78.0%)- decrease in low-density lipoprotein cholesterol with LSM diff. (-0.403 mmol/L)- non-inferiority data with mean arterial pressure with LSM diff. (-0.372 mmHg)- safety & AEs (91.6% vs 92.5%)- MACE (0.81 vs 0.90)- Presented at ERA-EDTA 2020
- Roxadustat (PO) is a novel inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) which leads to increment in hemoglobin levels- approved and launched for anemia associated with CKD in Japan in DD patients and in China for both DD and NDD patients
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