A phase 3 trial of difelikefalin in hemodialysis patients with pruritus
New England Journal of Medicine Jan 23, 2020
Fishbane S, et al. - Experts designed double-blind, placebo-controlled, phase 3 trial to analyze the impact of difelikefalin in hemodialysis patients with pruritus. In this trial, individuals (undergoing hemodialysis who had moderate-to-severe pruritus) were assigned randomly to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks. The primary endpoint was the percentage of individuals with an improvement (decrease) of at least 3 points from baseline at week 12 in the weekly mean score on the 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS; scores range from 0 to 10, with higher scores indicating greater itch intensity). The change from baseline in itch-related quality-of-life measures, the percentage of patients with an improvement of at least 4 points in the WI-NRS score at week 12, and safety were considered as a secondary endpoint. They randomized a sum of 378 individuals. In comparison with those who received a placebo, they found that individuals treated with difelikefalin had a significant reduction in itch intensity and improved itch-related quality of life.
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