p<0.0001). Roxadustat reduced hepcidin from baseline by a mean of 30.2 ng/ml (p=0.003) compared to a reduction of 2.3 ng/ml in the epoetin alfa group (p=0.12).
In subgroup analysis based on the baseline CRP levels, which indicates the patient’s inflammation status, roxadustat demonstrated consistent efficacy in hemoglobin control regardless of CRP levels without increase in roxadustat dose requirements, while epoetin alfa patients with elevated baseline CRP levels showed lower hemoglobin response despite receiving higher average doses of epoetin alfa compared to the doses patients with normal baseline CRP levels received. In the subgroup of inflamed patients (as measured by elevated CRP), mean change in hemoglobin from baseline to Weeks23-27 were significantly higher in roxadustat than EPO, p=0.0034.
Roxadustat appeared to be well-tolerated in this study, there were no safety signals, and the most frequent treatment emergent adverse events were typical for this population.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Roxadustat(FG-4592) for Treatment of Anemia in Subjects with CKD Not on Dialysis
Presenters: Chen Nan, Shanghai Ruijin Hospital and Hao Chuanming, Shanghai Huashan Hospital
Abstract:TH-PO1153
Results
152 patients were randomized and received either roxadustat (n=101) or placebo (n=51) in the initial eight weeks. Subjects in the roxadustat arm had a greater mean (+SD) change from baseline in hemoglobin of 1.9 g/dL (±1.2) (mean baseline hemoglobin 8.9 (±0.8) g/dL), as compared to the mean change in the placebo group of-0.4 g/dL (±0.8) from a mean baseline of (8.9 (±0.7) g/dL (p<0.0001). At Week 9, patients in roxadustat group had a greater mean reduction in hepcidin of-56.14 (±63.40) (p<0.0001) vs.-15.10 (±48.06) ng/ml (p=0.17) in the placebo group (p<0. 0001 between groups). At Week 9, the decline from baseline in total cholesterol and LDL cholesterol in the roxadustat arm were larger than placebo (p<0.0001).
Following the initial eight-week period, all subjects continuing on study received roxadustat for an18-week, open-label treatment period enabling patients initially randomized to placebo to have crossover to roxadustat. Among subjects treated with roxadustat during the initial eight weeks, hemoglobin remained stable for the subsequent18-week, open-label period with an overall change from baseline of +1.9 (±1.3) g/dL over Weeks23-27, with 79.7% of subjects achieving a hemoglobin³11.0 g/dL during the26-week treatment, and 71.1% achieved a mean hemoglobin³10.0 g/dL averaged over Weeks23-27. Among patients treated with placebo during the initial double-blind period, hemoglobin increased from baseline by 2.0 (±1.5) g/dL upon crossing over to roxadustat treatment (p<0.0001), 72.1% of subjects achieved a hemoglobin >11.0 g/dL during the last18-weeks of treatment, and 86.0% achieved a mean hemoglobin >10.0 g/dL averaged over Weeks23-27.
Roxadustat appeared to be well-tolerated in this study, there were no safety signals, and the most frequent treatment emergent adverse events were typical for this population.
About StudiesFGCL-4592-808 andFGCL-4592-806 in China
FGCL-4592-806is a multi-center, randomized, epoetin alfa-controlled, open-label Phase 3 study in 304 patients on dialysis conducted over 26 weeks. CKD patients on chronic dialysis (whose anemia was
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