Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease Martin et al. Am J Nephrol 2017;45:380-388 (DOI:

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Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease Martin et al. Am J Nephrol 2017;45:380-388 (DOI: 10.1159/000464476) Table 1. Baseline patient characteristics (ITT and mITT populations)

Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease Martin et al. Am J Nephrol 2017;45:380-388 (DOI: 10.1159/000464476) Fig. 1. Effect of trial treatment on hemoglobin (Hb) at week 6 (modified intent to treat population). For patients who underwent dose reduction during the trial, end-of-treatment Hb was defined as the Hb immediately preceding dose reduction. Five (26%) of the patients in the 630 mg vadadustat treatment group, 2 (12%) of patients in the 500 mg vadadustat treatment group and 2 (11%) of patients in the 240 mg group underwent protocol-defined dose reductions by week 4. Imputation was not performed for missing values, and missing values were excluded from analysis. a Mean changes in Hb (±SEM) compared to baseline. A one-way analysis of variance test was performed with change from baseline as the dependent variable and treatment group as the independent variable. * p < 0.05 for comparisons with baseline. †p < 0.05 for comparisons with placebo. b Proportion of trial patients who achieved increases in Hb ≥1 g/dL at week 6 compared with baseline.

Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease Martin et al. Am J Nephrol 2017;45:380-388 (DOI: 10.1159/000464476) Fig. 2. Observed mean hemoglobin (Hb) concentration over the trial period during administration of vadadustat or placebo (modified intent to treat population). Data are expressed as the mean ± SEM Hb value at each time point. * p < 0.05 for comparisons with baseline. † p < 0.05 for comparisons with placebo.

Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease Martin et al. Am J Nephrol 2017;45:380-388 (DOI: 10.1159/000464476) Fig. 3. Observed mean ferritin concentration and total iron binding capacity (TIBC) over the trial period during administration of vadadustat or placebo (modified intent to treat population). Data are expressed as the mean ± SEM at each time point. a Mean change in ferritin concentration (±SEM) compared to baseline. B Mean change in TIBC compared to baseline. c Mean change in hepcidin concentration compared to baseline. * p < 0.05 for comparisons with baseline. † p < 0.05 for comparisons with placebo.