Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program.

ABSTRACT:

Rationale & objective

We report a pooled safety analysis of intravenous difelikefalin in participants with moderate to severe chronic kidney disease-associated pruritus (CKD-aP) treated by hemodialysis in 4 phase 3 clinical studies.

Study design

KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.

Setting & participants

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

Intervention

At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.

Outcomes

Safety.

Results

Safety analyses were conducted with 848 participants in the placebo-controlled coho

SUBMITTER: Fishbane S 

PROVIDER: S-EPMC9418597 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature