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

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 μg/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

SUBMITTER: Fishbane S 

PROVIDER: S-EPMC7210745 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature