Trial reportBMC nephrology2026
Efficacy and safety of anrikefon in the treatment of diabetic hemodialysis patients with pruritus: a post hoc analysis.
Trial report in BMC 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
backgroundDiabetic kidney disease (DKD) is a leading cause of chronic kidney disease worldwide and diabetes predisposes patients to pruritus. Anrikefon is a novel selective peripherally restricted kappa-opioid receptor agonist. This post hoc analysis utilized data from phase 3 anrikefon-302 study to investigate the efficacy and safety of anrikefon in the treatment of diabetic hemodialysis patients with pruritus.
methodsThis is a post hoc analysis of data collected in a randomized, placebo-controlled phase 3 study. Diabetic hemodialysis patients were included (anrikefon n = 67 and placebo n = 79). The percentage of patients achieving at least a 4-point or 3-point reduction in weekly mean 24 hour worst itching intensity numerical rating scale (WI-NRS) score from baseline to week 12 were analyzed. The changes in itch related quality of life from baseline using the Skindex-10 and 5-D itch scales were also compared.
resultsThe baseline demographics and characteristics were generally similar in the individual placebo and anrikefon treatment arms. Interestingly, significantly more patients reported a clinically meaningful ≥ 4-point (29.9% versus 15.2%; p = 0.033) and ≥3-point (41.8% versus 20.3%; p = 0.012) reduction from baseline to week 12 in WI-NRS for the anrikefon group versus placebo. Furthermore, the change in WI-NRS score was significantly greater in patients receiving anrikefon treatment than in those in the placebo control group [-2.86 (SE 0.26) versus -1.63 (SE 0.21); p = 0.001]. Moreover, the mean change from baseline in the Skindex-10 itch score at week 12 was -16.25 (SE 1.52) in the anrikefon group and -8.49 (SE 1.36) in the placebo group (p < 0.001). The mean change from baseline in the 5-D itch score at week 12 was -5.41 (SE 0.45) in the anrikefon group and -3.20 (SE 0.38) in the placebo group. Moreover, the incidence of treatment emergent adverse events was comparable between the two groups.
conclusionsAnrikefon resulted in a noticeable reduction in itch intensity and an improvement in itch related quality of life in diabetic hemodialysis patients with pruritus.
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