POS-282 ROXADUSTAT TREATMENT RESULTS IN CONSISTENT IMPROVEMENTS IN HEMOGLOBIN (HB) VERSUS PLACEBO: AN ANALYSIS OF THREE MULTINATIONAL RCTS IN PATIENTS WITH NON-DIALYSIS-DEPENDENT CHRONIC KIDNEY DISEASE (NDD-CKD)

Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor that increases endogenous erythropoietin and enhances iron utilization. To evaluate the consistency of Hb across studies global geographic regions, we analyzed data from three pivotal Phase 3 trials roxadustat in patients with anemia NDD-CKD. While based on same trial design, were performed by different investigators companies differing regions. Patients baseline <10 g/dL eGFR <60 mL/min/1.73 m2 not dialysis randomized to or placebo OLYMPUS (North South America, Asia-Pacific Europe; N=2781, 1:1 ratio placebo), ALPS (South Europe Africa; N=597, 2:1 ANDES Australasia; N=922; placebo) double-blind controlled (RCTs). Oral was administered unrestricted; intravenous (IV) limited rescue therapy those low stores poor treatment response. The primary endpoint mean change average over Weeks 28–52. Significant (P<0.001) consistent improvements observed vs all (Figure) maintained time. IV use lower (Figure). Overall safety comparable CKD patient population. consistently improved NDD-CKD clinical program, varying locations.