ZS Pharma announced top-line results from the acute phase of its pivotal Phase 3 ZS-003 trial of ZS-9, an investigational treatment for hyperkalemia.
ZS-003 was a randomized, double-blind, placebo-controlled clinical trial that enrolled 753 patients with hyperkalemia (potassium 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, administered three times daily for the initial 48 hours (acute phase). The primary endpoint was the rate of change in serum K+ from baseline throughout the 48 hour acute phase.
Top-line preliminary results from the acute phase showed significant, rapid, and dose-dependent reductions in serum K+ at the 2.5g, 5g, and 10g doses. The trial met the primary efficacy endpoint for the acute phase at the 2.5g, 5g, and 10g doses compared with placebo (P=0.0009, P<0.0001, and P<0.0001 respectively). Mean serum K+ reduction was -0.73 mEq/L at the 10g dose at 48 hours (P<0.0001), 14 hours after the last dose.
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