Phase III KALM-1 trial of Korsuva for chronic kidney disease-associated pruritus published in NEJM.- Cara Therapeutics

Cara Therapeutics announced that the New England Journal of Medicine (NEJM) published full results from the randomized, double-blind pivotal Phase III (KALM-1) trial of Korsuva (difelikefalin injection) in patients undergoing hemodialysis with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). The paper, titled �A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus,� summarizes data from 378 patients, randomized to receive intravenous bolus difelikefalin at a dose of 0.5 mcg/kg or placebo at the end of each dialysis session, administered over a 12-week treatment period.

Overall, 51.9% of patients in the difelikefalin group achieved the pre-specified primary outcome of a three point or greater improvement in the weekly mean of the daily worst itch intensity numeric rating scale (WI-NRS) versus 30.9% in the placebo group at week 12. In an additional analysis conducted for NEJM, the imputed proportion of patients achieving the primary outcome was 49.1% in the difelikefalin group, as compared to 27.9% in the placebo group (p<0.001) at week 12. difelikefalin treatment also resulted in statistically significant improvements in the proportion of patients achieving a four point or greater improvement in wi-nrs, as well as in itch-related quality of life measures, as assessed by the 5-d itch and skindex-10 scales, from baseline to week 12. diarrhea, dizziness, and vomiting were more common in the difelikefalin group than the placebo group, consistent with earlier clinical trials of difelikefalin in hemodialysis patients with ckd-ap.>

See: "A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus" Steven Fishbane et al. NEJM November 8, 2019 DOI: 10.1056/NEJMoa1912770