Supplementary Material for: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Desidustat's Efficacy and Safety in Non-Dialysis Chronic Kidney Disease Patients with Anemia

Background: This phase III trial assessed desidustat’s efficacy and safety compared with placebo for the treatment of anemia in non-dialysis-dependent chronic kidney disease (NDD-CKD). Methods: A multicenter, randomized, double-blind trial enrolled 152 NDD-CKD patients with anemia (101 desidustat, 51 placebo). Primary endpoint: hemoglobin (Hb) change from baseline to weeks 7-9. Secondary endpoints included Hb response rate (≥100 g/L), time to target Hb, and target Hb maintenance (100–120 g/L). Safety evaluated treatment-emergent adverse events (TEAEs). Exploratory endpoints analyzed Hb dynamics (weeks 21-25) and serum hepcidin levels (baseline-week 53). Results: After 9 weeks of treatment, desidustat increased hemoglobin level from 89.18 g/L to 105.66 g/L, whereas placebo decreased from 89.41 g/L to 88.51 g/L, with a mean difference of 17.52 g/L (95% CI: 14.35–20.68) in the FAS. And in the PPS, desidustat increased hemoglobin level from 88.86 g/L to 105.62 g/L, and placebo declined from 89.37 g/L to 87.57 g/L, with a mean difference of 18.39 g/L (95% CI: 15.39–21.39). Hb response rates were 85.15% vs. 23.53% (P