Trials & Filings

La Jolla Launches Extension Study

12-week program continues with CKD patients

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

La Jolla Pharmaceutical has started a Phase II Extension study of GCS-100 in chronic kidney disease (CKD). The extension study was initiated at the request of the trial’s lead investigators, to study long-term safety and efficacy of GCS-100 in patients who completed the initial 12-week Phase II study. The study will enroll CKD patients who completed the 12-week Phase II study, including a maximum of 115 patients at five sites. Subjects will be randomly assigned 1:1 to treatment with 1.5 m...

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