Cara Therapeutics completes enrollment of KALM-1 Phase 3 trial of Korsuva

Cara Therapeutics announced completion of enrollment in the KALM-1 Phase 3 trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus. More than 350 hemodialysis patients with CKD-aP have now been randomized across approximately 60 clinical sites in the United States. KALM-1 is a multicenter, randomized, double-blind, placebo-controlled 12-week treatment trial in the U.S. with a 52-week open label extension phase that is designed to evaluate the safety and efficacy of 0.5 mcg/kg KORSUVA CR845/difelikefalin injection in 350 hemodialysis patients with moderate-to-severe pruritus. The primary efficacy endpoint is the proportion of patients achieving at least a 3-point improvement from baseline in the weekly mean of the daily 24-hour Worst Itch Numeric Rating Scale score at week 12. In a completed Phase 2 trial, the proportion of patients with an improvement from baseline in the weekly mean Worst Itch NRS score of greater than or equal to3 points at week 8 was statistically significantly higher in the CR845/difelikefalin 0.5 mcg/kg group compared to the placebo group . Secondary endpoints include assessment of itch-related quality of life changes measured using the validated self-assessment 5-D itch and Skindex-10 scales, as well as the proportion of patients achieving greater than 4-point improvement from baseline in weekly mean of the daily 24-hour Worst Itch NRS score at week 12.

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