(RTTNews.com) - Cara Therapeutics, Inc. ( CARA ) announced the completion of an interim statistical analysis of its pivotal KALM-1 Phase 3 trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus. The company said, based on the recommendation of the Independent Data Monitoring Committee, the trial will continue as planned with no changes to the original enrollment target of 350 patients.
Derek Chalmers, CEO of Cara Therapeutics, said: "We are very pleased with the IDMC recommendation that the KALM-1 trial proceed as planned with no modifications, and we look forward to completing the study and reporting top-line data in the first half of this year."
The Phase 3 U.S. study is a multicenter, randomized, double-blind, placebo-controlled 12-week treatment trial (with a 52-week open label extension phase) that is designed to evaluate the safety and efficacy of 0.5 mcg/kg CR845/difelikefalin injection in 350 hemodialysis patients with moderate-to-severe pruritus.
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