Efficacy and safety of anrikefon in patients with pruritus undergoing haemodialysis: multicentre, double blind, randomised placebo controlled phase 3 trial.

ABSTRACT:

Objective

To evaluate the efficacy and safety of anrikefon (formerly known as HSK21542), a novel selective peripherally restricted kappa opioid receptor agonist, in patients with chronic kidney disease associated pruritus.

Design

Multicentre, double blind, randomised placebo controlled phase 3 trial.

Setting

50 centres in China, June 2022 to June 2024.

Participants

652 patients with moderate to severe CKD associated pruritus undergoing haemodialysis were screened: 545 were randomly assigned (1:1 ratio) to receive either anrikefon (n=275) or placebo (n=270).

Interventions

Intravenous anrikefon (0.3 μg/kg body weight) or placebo three times weekly for 12 weeks, followed by an optional open label extension phase with anrikefon treatment for 40 weeks.

Mai

SUBMITTER: Liu BC 

PROVIDER: S-EPMC12362199 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature