Trials & Filings

La Jolla Completes CKD Enrollment

Primary endpoint data due April 2014

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

La Jolla Pharmaceutical Co. has completed enrollment of its placebo-controlled, randomized Phase II trial of GCS-100 in patients with chronic kidney disease (CKD). A total of 121 patients with Stage 3b or 4 CKD were enrolled in the study. The company expects to announce data on the primary endpoint in April 2014 and the full data package before the end of 2Q14. The study was designed to enroll approximately 117 subjects, at least 18 years of age, with Stage 3b or 4 CKD. Subjects were randomly a...

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