Positive Results with ZS-9 for Hyperkalemia
ZS Pharma announced top-line results from its Extended Treatment Phase of ZS003, a Phase 3 trial of ZS-9 for the treatment of hyperkalemia.
This randomized, double-blind, placebo-controlled clinical trial enrolled 753 patients with hyperkalemia (K+ levels 5–6.5 mEq/L), including patients with chronic kidney disease (CKD), heart failure, diabetes, and those on renin angiotensin aldosterone system (RAAS) inhibitor therapy. Patients were randomized to receive one of four doses of ZS-9 (1.25g, 2.5g, 5g or 10g) or placebo three times daily for the initial 48 hours in the Acute Phase. The primary endpoint of the clinical trial was the rate of change in serum K+ from baseline throughout the 48-hour dosing period. Patients whose serum potassium was normalized in the Acute Phase were then randomized to the Extended Treatment Phase.
In the Extended Treatment Phase, patients were randomized to one of four doses of ZS-9 (1.25g, 2.5g, 5g or 10g) or placebo administered once daily for an additional 12 days. The endpoint of the Extended Treatment Phase of the clinical trial was the rate of change in serum K+ over the 12-day dosing period.
Results from the Extended Treatment Phase demonstrated that both 5g and 10g of ZS-9 maintained a statistically and clinically significant reduction in serum potassium (K+) relative to placebo (P-values of 0.0075, and <0.0001, respectively) over 12 days. The trial also met the endpoint for the Acute Phase, demonstrating a rapid, statistically significant reduction in K+ over the initial 48 hours at doses of 2.5g, 5g and 10g.For more information call (650) 458-4100 or visit ZSPharma.com.