Safety and Effectiveness of Difelikefalin in Patients With Moderate-to-Severe Pruritus Undergoing Hemodialysis: An Open-Label, Multicenter Study.

ABSTRACT:

Rationale & objective

Individuals with chronic kidney disease frequently suffer from chronic kidney disease-associated pruritus (CKD-aP), impacting sleep quality and quality of life (QoL) and increasing the likelihood of depression. Difelikefalin is a kappa-opioid receptor agonist recently approved in the United States for the treatment of moderate-to-severe CKD-aP in hemodialysis patients. Study 3105 was conducted to further assess the safety of difelikefalin and the effects on pruritus and QoL.

Study design

Open-label, multicenter, single-arm intervention trial.

Setting & participants

Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.

Intervention

Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.

SUBMITTER: Weiner DE 

PROVIDER: S-EPMC9516453 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature