In January 2018, based on positive data from Phase 2 clinical trials1 and after completion of the End-of-Phase 2 meeting with the FDA, Cara initiated the first pivotal Phase 3 trial of KORSUVA injection (KALM-1 trial) in hemodialysis patients suffering from moderate-to-severe CKD-aP in the United States (additional information about the study can be found at www.clinicaltrials.gov, ID: NCT03422653). Cara also expects to initiate a global Phase 3 clinical trial of KORSUVA injection for the treatment of CKD-aP in hemodialysis patients in multiple countries later this year. Data from these studies are expected to support filings for regulatory approvals in the U.S. and other markets.
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