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February 21, 2014
08:02 EDTLJPCLa Jolla Pharmaceutical announces final dosing in GCS-100 phase 2 trial
La Jolla Pharmaceutical announced that it has completed dosing of its Phase 2 clinical trial of GCS-100 for the treatment of chronic kidney disease and has collected the final data for evaluation of the primary endpoint. The primary efficacy endpoint is the change in estimated glomerular filtration rate from baseline to the average at day 50 and 57 in each GCS-100 dose group compared to placebo. The primary endpoint will be reached if the difference in eGFR between either GCS-100 dose group and placebo has a significance of less than 10%. Of the 121 subjects with Stage 3b or 4 CKD enrolled, 117 subjects completed the study with no discontinuation due to an adverse event. Subjects were randomly assigned 1:1:1 to treatment with placebo, 1.5 or 30 mg/m2 of GCS-100. In addition, randomization was stratified by baseline renal function, defined by eGFR values of 15-29 and 30-44 mL/min/1.73m2. Once randomized, subjects received eight consecutive weekly doses of their assigned treatment with a follow-up four weeks after treatment.
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