La Jolla Completes CKD Enrollment

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 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 receive eight consecutive weekly doses of their assigned treatment with a follow-up four weeks after treatment.

The primary objective of this study is to compare the change in eGFR from baseline to the end of treatment between placebo and GCS-100 treatment. The secondary objective is to determine the safety and tolerability of GCS-100 administered for eight weeks relative to placebo. In addition, the study measures the effect of GCS-100 on circulating galectin-3 and other markers of disease activity.