Influence of Concomitant Opioids on Difelikefalin Treatment Outcomes in Adults with Moderate-to-Severe Pruritus on Maintenance Hemodialysis: Exploratory Analyses.

ABSTRACT:

Introduction

Difelikefalin (DFK) is approved to treat chronic kidney disease-associated pruritus (CKD-aP) in adults undergoing maintenance hemodialysis. The influence of concomitant opioid use on DFK treatment outcomes remains uncertain.

Methods

Exploratory analyses were conducted from the phase 3, placebo (PBO)-controlled KALM-1 and KALM-2 trials (datasets pooled), and the phase 3, open-label, single-arm Study 3105. Each trial assessed the safety and efficacy of DFK 0.5 µg/kg in adults with moderate-to-severe CKD-aP. We report key endpoints from the primary studies, including reduction in itch intensity (Worst Itching Intensity Numerical Rating Scale [WI-NRS]), and improvements in itch-related quality of life (QoL; 5-D itch and Skindex-10), according to concomitant opioid u

SUBMITTER: Burton JO 

PROVIDER: S-EPMC12803522 | biostudies-literature | 2026

REPOSITORIES: biostudies-literature