ArticleAmerican journal of nephrology2026
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.
Article in American journal of nephrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionThis 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).
methodsA 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).
resultsAfter 9 weeks of treatment, desidustat increased Hb 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% confidence interval [CI]: 14.35-20.68) in the full analysis set. And in the per protocol set, desidustat increased Hb 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 < 0.001). Median time to target Hb was 30 days with desidustat vs. 0 days with placebo (p < 0.001). By week 9, desidustat maintained Hb within target range 51.68% of the time vs. 10.24% for placebo (p < 0.001). TEAE incidence was comparable between groups. During weeks 21-25, Hb rose further (desidustat: +21.26 g/L; placebo: +26.63 g/L). Serum hepcidin decreased sharply in desidustat by week 9 (-67.43 ng/mL vs. -6.38 ng/mL; placebo), though placebo showed delayed reduction by week 25 - levels equalized by week 53.
conclusionDesidustat significantly improved Hb levels and accelerated anemia correction in NDD-CKD patients versus placebo, with comparable safety.
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