Cara to increase enrollment in second late-stage study of Korsuva in CKD-aP

Based on an interim statistical analysis by the Independent Data Monitoring Committee, Cara Therapeutics (NASDAQ:CARA) will boost enrollment by ~20% to 430 subjects in its Phase 3 clinical trial, KALM-2, evaluating KORSUVA (CR845/difelikefalin) in patients on dialysis with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) (itchy skin).

The increase is necessary in order to maintain at least 90% statistical power on the primary endpoint (the proportion of patients achieving at least a three-point improvement in a scale called NRS at week 12).

Enrollment should be completed this quarter. The company still expects to file a U.S. marketing application in H2 2020.

Another Phase 3, KALM-1, was successful.

https://seekingalpha.com/news/3505441-cara-increase-enrollment-second-late-stage-study-korsuva-ckd-ap