Study endpoints
SECONDARY
The primary endpoint was the safety evaluation regarding AEs, changes in laboratory values, vital signs, and standard 12-lead electrocardiograms. Changes in Bristol Stool Form Scale score and stool frequency were also assessed.The key secondary endpoint was the achievement of a ≥ 30% reduction in the total pill number of phosphate binders and tenapanor prescribed daily in the last 3 weeks before Week 52 or the time of discontinuation compared with the pill number of phosphate binders prescribed daily at baseline.Secondary endpoints included the following: the total daily pill number, weight, and volume of phosphate binders and tenapanor at each time point; achievement of a ≥ 30% decrease from the pill number of phosphate binders and tenapanor prescribed daily at each time point compared with the pill number of phosphate binders at baseline; their changes and percentage from baseline; and serum phosphorus levels and changes from baseline at each time point.