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Completion of interim statistical assessment and small increase in target enrollment for KALM-2 phase III trial of Korsuva injection

Read time: 1 mins
Last updated:23rd Oct 2019
Published:15th Oct 2019
Source: Pharmawand

Cara Therapeutics, Inc. announced the completion of an interim statistical assessment of its pivotal KALM-2 Phase III global clinical trial of Korsuva (CR845/difelikefalin) Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Based on the Independent Data Monitoring Committee’s (IDMC) recommendation, the size of the trial will be increased by approximately 20 percent, from an original enrollment target of 350 patients to 430 patients, to maintain the pre-specified statistical power of 90 percent or greater on the trial’s primary endpoint.

The IDMC charter allowed for the trial size to be increased up to a maximum of 500 patients. The IDMC’s recommendation was based on the results of a prespecified interim conditional power assessment conducted after approximately 50 percent of the targeted patient number completed the designated 12-week treatment period.

“The IDMC recommendation to increase the target enrollment of KALM-2 aligns with our objective to maintain similar statistical power in this global trial to that of our positive KALM-1 US trial,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “As we have already randomized a significant number of patients in KALM-2, beyond the initial target enrollment of 350, we expect the trial to be fully enrolled by the end of this quarter and and remain on track to file our New Drug Application (NDA) for Korsuva Injection for the treatment of moderate-to-severe CKD-aP in hemodialysis patients in the second half of 2020.”.

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