Randomized Controlled Trial of Difelikefalin for Chronic Pruritus in Hemodialysis Patients.

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Fishbane S, Mathur V, Germain MJ, Shirazian S, Bhaduri S, Munera C, Spencer RH, Menzaghi F

Randomized Controlled Trial of Difelikefalin for Chronic Pruritus in Hemodialysis Patients.

Kidney Int Rep. 2020 Jan 28;5(5):600-610. doi: 10.1016/j.ekir.2020.01.006. eCollection 2020 May.

PubMed ID

32405581 [ View in PubMed

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Abstract

Introduction: There is an unmet medical need for pruritus associated with chronic kidney disease, a distressing complication characterized by generalized and persistent itch affecting 20% to 40% of patients undergoing hemodialysis. Here we report the results of a phase 2 trial evaluating the efficacy and safety of a novel peripherally restricted kappa opioid receptor agonist, difelikefalin, in adult patients undergoing hemodialysis with pruritus. Methods: In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 mug/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial. The primary endpoint was the change from baseline at week 8 in the weekly mean of the 24-hour Worst Itching Intensity Numerical Rating Scale score. The secondary efficacy endpoint was the change in itch-related quality of life measured by the Skindex-10 questionnaire. Other endpoints included safety, sleep quality, and additional measures including the 5-D itch scale. Results: A significant reduction from baseline in itch intensity scores at week 8 favored all difelikefalin doses combined versus placebo (P = 0.002). Difelikefalin also showed improvement over placebo in Skindex-10, 5-D itch, and sleep disturbance scores (P /=5%). Conclusion: In this trial, difelikefalin effectively reduced itching intensity and improved sleep and itch-related quality of life.

DrugBank Data that Cites this Article

Drug Targets

Drug	Target	Kind	Organism	Pharmacological Action	Actions
Difelikefalin	Kappa-type opioid receptor	Protein	Humans	Yes	Agonist	Details