Efficacy of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis of KALM-1 and KALM-2 Phase 3 Studies.

ABSTRACT:

Rationale & objective

Chronic kidney disease-associated pruritus (CKD-aP) in patients treated by hemodialysis (HD) impairs quality of life (QoL). Difelikefalin, a selective κ-opioid receptor agonist, decreased the intensity of CKD-aP in patients undergoing HD. This pooled analysis evaluated difelikefalin's efficacy and the itch-related QoL overall and in subgroups defined by demographics or disease characteristics.

Study design

In KALM-1 and KALM-2, participants were randomized (1:1) to receive intravenous difelikefalin or placebo 3 times/wk for 12 weeks, followed by a 52-week open-label extension.

Setting & participants

Adults with moderate to severe CKD-aP treated by HD in North America, Europe, and the Asia-Pacific region.

Intervention

Intravenous difelikefa

SUBMITTER: Topf J 

PROVIDER: S-EPMC9396406 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature