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ZS Pharma completes patient enrollment in phase III trial of hyperkalemia treatment

ZS Pharma, a US-based biopharmaceutical firm, has completed patient enrollment in its second phase III clinical trial (ZS004) of ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalemia.

The trial is designed to confirm the positive results previously reported for ZS003, a phase III trial in which once-daily doses of ZS-9 maintained potassium levels within the normal range with safety and tolerability similar to placebo.

A total of 258 patients with hyperkalemia were enrolled at 42 participating sites in the ZS004 trial, which started in March 2014.

The company expects to report top-line results from the phase III trial late in the third quarter or early in the fourth quarter of 2014.

ZS Pharma chief executive officer Robert Alexander said completion of enrollment in ZS004 is a major step in advancing the ZS-9 global development program toward planned NDA and MAA submissions in the first half of 2015.

"It also brings us one step closer to potentially making ZS-9 available to patients who need new treatment options for hyperkalemia," Alexander said.

The randomized, double-blind, placebo-controlled trial included patients with hyperkalemia (potassium levels >5 mEq/L), as well as patients with chronic kidney disease (CKD), heart failure, diabetes, and those on renin angiotensin aldosterone system (RAAS) inhibitor therapy.

In the open-label induction phase of the trial, patients were given 10g of ZS-9 administered three times daily for 48 hours.

The company said that patients who achieved normokalemia were eligible to be randomized in a double-blind fashion to one of three doses of ZS-9 (5g, 10g or 15g) or placebo administered once-daily for 28 days.