Randomized Double-Blind Trial of WS016 in Chinese Patients With Hyperkalemia

Introduction WS016 is a highly selective cation exchanger which traps potassium in the intestinal tract, reducing serum potassium levels in patients with hyperkalemia. This study aimed to evaluate the efficacy and safety of WS016 in hyperkalemic patients. Methods One hundred forty eligible patients were randomized to receive either WS016 (3 g, 6 g, or 12 g), thrice daily, or placebo for 48 hours. Among those who achieved normokalemia, patients were randomized to WS016 (3 g, 6 g, and 12 g), once daily for 12 days. The primary outcome was the exponential rate of change in serum potassium levels from baseline over the acute and maintenance treatment period, respectively. Results During the acute treatment phase, the mean exponential rates of reduction from baseline were 0.19% ( P = 0.27), 0.17% ( P = 0.35), and 0.33% ( P < 0.0001) per hour in the WS016 3 g, 6 g, and 12 g group, respectively, compared with a 0.13% with placebo. In contrast, during the maintenance phase, all WS016 groups showed a numerically slower mean daily increase in serum potassium compared with their corresponding placebo groups. The daily increase rate was 0.90% with WS016 12 g versus 1.24% with placebo, the difference was −0.34% (95% confidence interval [CI]: −1.30% to 0.63%; P = 0.49). The overall incidence of adverse events was comparable between WS016 and placebo groups as follows: 26.9% (WS016) versus 20.0% (placebo) during the acute phase and 27.0% versus 31.3% in the maintenance phase. Conclusion WS016 reduced serum potassium levels rapidly and maintained more patients within the normokalemic range.